HSA · registration DE0508373Acra-Cut AcraClip Disposable Scalp Clips
SingaporeGeneral & Plastic SurgeryClass BAcra-Cut Inc.
Official record identity
- Registration number
- DE0508373
- Model name
- Reusable Acragun with sterilizing case; Straight Edge, Heavy Force, Adult Scalp, two 15-clip cartridges; Serrated Edge, Light Force, Pediatric Scalp, two 15-clip cartridges; Serrated Edge, Medium Force, Adult Scalp, two 15-clip cartridges; Serrated Edge, Heavy Force, Adult Scalp, two 15-clip cartridges; Straight Edge, Medium Force, Adult Scalp, one 15-clip cartridge; Straight Edge, Heavy Force, Adult Scalp, one 15-clip cartridge; Serrated Edge, Light Force, Pediatric Scalp, one 15-clip cartridge; Serrated Edge, Medium Force, Adult Scalp, one 15-clip cartridge; Serrated Edge, Heavy Force, Adult Scalp, one 15-clip cartridge; Reusable Acra-Cut Clip Applier/ Remover
- Model identifier
- 500-100; 500-103; 500-104; 500-105; 500-106; 500-108; 500-109; 500-110; 500-111; 500-112; 500-135
- Registration date
- August 14, 2023
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Acra-Cut Inc.
- Registrant / registration holder
- HUMEDICAL (S) PTE. LTD.
Official description
ACRACLIPS are disposable scalp clips designed for use with the reusable ACRAGUN (Model 500-100). ACRACLIPS are for hemostasis of the scalp flap edges during cranial surgery.
Additional source fields
- Product owner address
- 989 Main Street, Acton, Massachusetts, 01720, United States
- Registrant address
- 3791 JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.