Identity
- Trade Name
- COUNTER BLADE, 14 X 110 MM EUDAMEDTSI FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- RETRACTOR BLADE EUDAMEDCOUNTER BLADE, 14 X 110 MM FDA UDI
- Model / Reference
- ML-0382 EUDAMEDFDA UDI
- Description
- COUNTER BLADE, 14 X 110 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059113600 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591RETRACTORBLADED8 EUDAMED
- Direct Marketing DI
- 00843059113600 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0199 SHARP INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nail scissors, reusable
Counter Blade, 14 X 110 Mm by TeDan Surgical Innovations, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 8430591RETRACTORBLADED8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TeDan Surgical Innovations, Inc.
- EUDAMED SRN
- US-MF-000016933
- Authorised Representative
- TeDan Surgical Innovations B.V. NL-AR-000002696
Sources (2)
- EUDAMED a141218b-7a7a-4cfa-84fc-6e2c9f200064 61 fields · synced Jul 22, 2026
- FDA UDI 7d8db8ef-38bc-4f47-b519-e1b1f8e11b19 33 fields · synced May 30, 2026