STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Bi-Directional) - Indonesia BPOM Medical Device Registration
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Bi-Directional) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603422191. The device is manufactured by ETHICON, LLC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ETHICON, LLC.Country of Origin
United States
Authorized Representative
JOHNSON AND JOHNSON INDONESIA TWOAR Address
K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A.
Registration Date
Sep 19, 2024
Expiry Date
Mar 25, 2029
Product Type
Surgical Equipment
Absorbable polydioxanone surgical suture.
Non Electromedic Sterile
PROLENE Polypropylene Mesh
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device
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