FDA UDI
In Commercial Distribution
🇺🇸 United States
Swann Morton Ltd.
DI: 05033955056919
·
Model: No. 11P BULK NON STERILE KLEEN BLADE MANAGEMENT SYSTEM
·
SWANN-MORTON LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Swann Morton Ltd.
- Primary DI
- 05033955056919
- Version / Model
- No. 11P BULK NON STERILE KLEEN BLADE MANAGEMENT SYSTEM
- Catalog Number
- 5691
- Company Name
- SWANN-MORTON LIMITED
- Labeler DUNS
- 212397483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-05-13
- Public Version
- 1
- Public Version Date
- 2022-05-23
- Public Version Status
- New
- Public Device Record Key
- 50876907-237a-46a0-a851-13dffef49a9b
Device Description
Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable.
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 |
|---|---|---|---|---|
| GES | Blade, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37445 | Manual scalpel blade, single-use | An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. 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 | 05063043056910 | GS1 | ||||
| Primary | 05033955056919 | GS1 |
Customer Contacts
- Phone
- +4401142344231
- [email protected]