FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 03596010513809
·
Model: 7210567
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 03596010513809
- Version / Model
- 7210567
- Catalog Number
- 7210567
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-12
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 1977cc95-e91e-4377-ab05-eb0dc62590b0
- Distribution End Date
- 2022-03-17
Device Description
MTO PAD TFS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWZ | Accessories, operating-room, table (kit) | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41542 | Leg/knee cushion | A soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010513809 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]