Tissue Punch 5.0mmD, S-5.5
by Adin Dental Implant Systems LTD.
Ref GS5055Model Tissue Punch
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The Tissue Punch 5.0mmD, S-5.5 device is a medical tool used for tissue sampling and preparation. It is designed to provide high-quality samples for various medical applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number729010930GuidTissuPunchBR 07290109300290 | Date20 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290109300290 | Date8 Dec 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Dental soft-tissue coring punch, reusable
- Model / Reference
- Tissue Punch, GS5055
- Primary DI / UDI-DI
- 07290109300290
- Basic UDI-DI
- 729010930GuidTissuPunchBR
- FDA Product Code
- NDP
- EMDN Code
- L0399 General surgery instruments, reusable - other
- GMDN Term
- Dental soft-tissue coring punch, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.3980
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000014625
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Adin Dental Implant Systems Ltd.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No