FDA UDI
In Commercial Distribution
🇺🇸 United States
Swann Morton Ltd.
DI: 05033955035266
·
Model: STITCH CUTTER NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD
·
SWANN-MORTON LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Swann Morton Ltd.
- Primary DI
- 05033955035266
- Version / Model
- STITCH CUTTER NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD
- Catalog Number
- 3526
- Company Name
- SWANN-MORTON LIMITED
- Labeler DUNS
- 212397483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2024-10-15
- Public Version
- 1
- Public Version Date
- 2024-10-23
- Public Version Status
- New
- Public Device Record Key
- ea7e5ae4-e3fb-4ded-8b26-be9294c99f6b
Device Description
A 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.
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
- Ethylene Oxide
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 | 05063043035267 | GS1 | ||||
| Primary | 05033955035266 | GS1 |
Customer Contacts
- Phone
- +4401142344231
- [email protected]