Identity
- Trade Name
- COUNTER BLADE, 14 X 130 MM EUDAMEDTSI FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- RETRACTOR BLADE EUDAMEDCOUNTER BLADE, 14 X 130 MM FDA UDI
- Model / Reference
- ML-0384 EUDAMEDFDA UDI
- Description
- COUNTER BLADE, 14 X 130 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059113624 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591RETRACTORBLADED8 EUDAMED
- Direct Marketing DI
- 00843059113624 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 130 Mm by TeDan Surgical Innovations, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nail scissors, reusable.
- Masako Instrumente — Marlas International · Class I
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
- Aesculap — Aesculap AG · Class I
- Gimmi — Gimmi GmbH · Class I
- box chisel — Atesos medical AG · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Flat-Blade Micro-Ringcurette φ1.0 31-5137 — CHARMANT INC. · Class I
- Aprikos Medical — Aprikos Medical AS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TeDan Surgical Innovations, Inc.
- EUDAMED SRN
- US-MF-000016933
- Authorised Representative
- TeDan Surgical Innovations B.V. NL-AR-000002696
Sources (2)
- EUDAMED 08348a36-0f40-4f80-bd0d-d51e4edf9caa 61 fields · synced Jul 16, 2026
- FDA UDI 611dda2c-2156-47a3-8202-05a6ff721136 33 fields · synced May 30, 2026