Taiwan FDA registration 780ee5b40e7a66bb49d28331c46abaf4

"Schneihui" bone void filler

TW: “史耐輝”骨空隙填補物

Taiwan·Risk Class 2·SMITH & NEPHEW INC. ENDOSCOPY DIVISION·Registered Mar 24, 2009 – Mar 24, 2014Cancelled

Registration details

Analysis ID: 780ee5b40e7a66bb49d28331c46abaf4
Customs Code: DHA00601997207

Company information

Manufacturer: SMITH & NEPHEW INC. ENDOSCOPY DIVISION
Manufacturer Country: United States
Authorized Representative: SMITH & NEPHEW ( OVERSEAS ) LIMITED, TAIWAN BRANCH (U.K.)

Product details

Intended Use: This injection is used to aspirate liquids, such as autologous blood, blood or other blood components, and mix well with the bone void filling material in the syringe. TRUGRAFT Granules are used to fill bone gaps in areas that are not related to the structural stability of the skeleton caused by trauma or surgery. The use is to use gentle force to insert filling materials (TRUGRAFT Granules) into the bony spaces of the bones (e.g. limbs, spine and pelvis). The bone gap may be caused by surgery or trauma. This product provides a filling to fill the bone void and the filling can be absorbed by the bone during the healing process. TRUGRAFT Granules can be mixed with autologous blood products, such as platelet-rich plasma, or sterilized liquids such as saline or Ringer's solution. The addition of these autologous products will not affect the efficacy of this device.
Product Type (Level 1): N Orthopedics
Import Information: import

Dates and status

Registration Date: Mar 24, 2009
Expiry Date: Mar 24, 2014
Cancellation Date: Sep 26, 2016

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Schneihui" bone void filler in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 780ee5b40e7a66bb49d28331c46abaf4 and manufactured by SMITH & NEPHEW INC. ENDOSCOPY DIVISION. The authorized representative in Taiwan is SMITH & NEPHEW ( OVERSEAS ) LIMITED, TAIWAN BRANCH (U.K.).

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