Identity
- Trade Name
- Needle Holder/Scissors 5.5" TC Tip EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Scissor EUDAMEDNeedle Holder/Scissors 5.5" TC Tip FDA UDI
- Model / Reference
- 3055 EUDAMEDFDA UDI
- Description
- Needle Holder/Scissors 5.5" TC Tip FDA UDI
Identifiers
- Catalog Number
- 3055 FDA UDI
- Primary DI / UDI-DI
- 00840277105165 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOSCIS01A7 EUDAMED
- Direct Marketing DI
- 00840277105165 EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L01041299 ORTHOPAEDIC SURGERY SCISSORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Needle Holder/Scissors 5.5" TC Tip by Innomed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNOSCIS01A7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED a1dd80f6-b089-453a-b7dd-8e62e1229372 61 fields · synced Jun 20, 2026
- FDA UDI 82b36ae4-d947-435e-830c-a22c71f74c14 34 fields · synced May 30, 2026