FDA UDI
In Commercial Distribution
🇺🇸 United States
Swann-Morton Limited
DI: 05033955023263
·
Model: STITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD
·
SWANN-MORTON LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Swann-Morton Limited
- Primary DI
- 05033955023263
- Version / Model
- STITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD
- Catalog Number
- 2326
- Company Name
- SWANN-MORTON LIMITED
- Labeler DUNS
- 212397483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 1
- Public Version Date
- 2025-09-02
- Public Version Status
- New
- Public Device Record Key
- bc845320-2873-4d78-a05b-f07ad6fd3e3c
Device Description
A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZT | Cutter, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05063043023264 | GS1 | ||||
| Primary | 05033955023263 | GS1 |
Customer Contacts
- Phone
- +4401142344231
- [email protected]