FDA UDI
In Commercial Distribution
🇺🇸 United States
Swann Morton Ltd.
DI: 05033955009236
·
Model: No. B3 STAINLESS SURGICAL HANDLES
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SWANN-MORTON LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Swann Morton Ltd.
- Primary DI
- 05033955009236
- Version / Model
- No. B3 STAINLESS SURGICAL HANDLES
- Catalog Number
- 0923
- Company Name
- SWANN-MORTON LIMITED
- Labeler DUNS
- 212397483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-27
- Public Version
- 1
- Public Version Date
- 2022-10-05
- Public Version Status
- New
- Public Device Record Key
- e42eec5e-aca6-4a4d-904b-25d5a0e48239
Device Description
Knife/blade handle. A metal surgical instrument e.g. stainless steel or brass, designed to mount a compatible blade used for cutting or dissecting tissue.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12235 | Scalpel handle, reusable | A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05033955009236 | GS1 |