Identity
- Trade Name
- EXEL SRGCL BLADE,S-S, SIZE:15 EUDAMEDFDA UDIEXEL Surgical Blade, Stainless Steel Size 15 EUDAMED
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- EXEL SURGICAL BLADE EUDAMEDEXEL SRGCL BLADE,S-S, SIZE:15; 100/BX, 1000/CS, 10CS/CRTN FDA UDI
- Model / Reference
- 29508 EUDAMEDFDA UDI
- Description
- EXEL SRGCL BLADE,S-S, SIZE:15; 100/BX, 1000/CS, 10CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 29508 FDA UDI
- Primary DI / UDI-DI
- 00020221295085 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221295085 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual scalpel blade, single-use
Exel Srgcl Blade, S-S, Size:15 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
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221295085 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221295085 | 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 2613f896-3224-4d49-b43c-26215e6e375f 61 fields · synced Jul 18, 2026
- FDA UDI c99d2478-cb49-4385-ac94-09b649827812 35 fields · synced May 30, 2026
- EUDAMED def9e1cb-a5e9-4003-bc7e-34f0f0ceb9f9 61 fields · synced Jul 18, 2026