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3 Lateral Blades, 18 X 140 Mm, Black
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ML-0925
Identity
- Trade Name
- 3 LATERAL BLADES, 18 X 140 MM, BLACK EUDAMEDTSI FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- RETRACTOR BLADE EUDAMEDBLADE SET, 18 X 140 MM, BLACK FDA UDI
- Model / Reference
- ML-0925 EUDAMEDFDA UDI
- Description
- BLADE SET, 18 X 140 MM, BLACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059120684 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591RETRACTORBLADED8 EUDAMED
- Direct Marketing DI
- 00843059120684 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
3 Lateral Blades, 18 X 140 Mm, Black by TeDan Surgical Innovations, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 3132e62b-29ed-4b0b-85f6-ddc6b7605026 61 fields · synced Aug 2, 2026
- FDA UDI 3cb5292a-fcfd-42f2-b186-4072e9c11e0b 33 fields · synced May 30, 2026