← Back to catalogue
DORO® Blade
FDA UDIClass I (US FDA UDI)
by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Identity
- Trade Name
- DORO® Blade FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- DORO® Blade Set 102 mm, Conical, Black Coated, 5 pcs consisting of: 3116-611 3116-621 3116-631 3116-641 3116-651 FDA UDI
- Model / Reference
- 3116-601 FDA UDI
- Description
- DORO® Blade Set 102 mm, Conical, Black Coated, 5 pcs consisting of: 3116-611 3116-621 3116-631 3116-641 3116-651 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435503430 FDA UDI
- FDA Product Code
- HAO FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical retractor/retraction system blade, reusable
DORO® Blade by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Medfix — Medfix International, LLC · Class I
- DELACROIX-CHEVALIER — LANDANGER · Class I
- MSI — Modern Surgical Instruments LLC · Class I
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medfix — Medfix International, LLC · Class I
- Specula Retractor Set — Koros USA, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 4becb96d-efb7-47e3-8baa-be28f33f412b 33 fields · synced May 30, 2026