Identity
- Trade Name
- Swann Morton Ltd. FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI
- Model / Reference
- No. 10A STERILE DISPOSABLE SCALPELS WITH GUARD FDA UDI
- Description
- A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI
Identifiers
- Catalog Number
- 6602 FDA UDI
- Primary DI / UDI-DI
- 05033955066024 FDA UDI
- FDA Product Code
- GDX FDA UDI
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Swann Morton Ltd. by Swann-Morton Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Swann-Morton Limited
Sources (1)
- FDA UDI 30f33afe-3b21-4109-bea7-e55fdbfd703d 36 fields · synced Jun 1, 2026