Identity
- Trade Name
- EXEL SURGICAL BLADE,S-S, SIZE:10 EUDAMEDEXEL Surgical Blade, Stainless Steel Size 10 EUDAMEDEXEL SRGCL BLADE,S-S, SIZE:10 FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- EXEL SURGICAL BLADE EUDAMEDEXEL SRGCL BLADE,S-S, SIZE:10; 100/BX, 1000/CS, 10CS/CRTN FDA UDI
- Model / Reference
- 29500 EUDAMEDFDA UDI
- Description
- EXEL SRGCL BLADE,S-S, SIZE:10; 100/BX, 1000/CS, 10CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 29500 FDA UDI
- Primary DI / UDI-DI
- 00020221295009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221295009 EUDAMED20221SURGBL295J4 EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMEDV010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Manual scalpel blade, single-use
Exel Surgical Blade, S-S, Size:10 by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221295009 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221295009 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 70ae7962-4110-413b-b077-2ead40baa891 61 fields · synced Jul 27, 2026
- FDA UDI fe7d35ef-c3da-4288-87e2-837e4b406a26 35 fields · synced May 30, 2026
- EUDAMED 7d14b8be-a732-4dd2-acde-3f534a902162 61 fields · synced Jun 18, 2026