FDA UDI
In Commercial Distribution
🇺🇸 United States
MedSource ABD Pads
DI: 00816703028766
·
Model: MS-ABD8X10-S
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MedSource ABD Pads
- Primary DI
- 00816703028766
- Version / Model
- MS-ABD8X10-S
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-26
- Public Version
- 3
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 97431077-dd76-400d-b38a-912240f28e13
Device Description
ABD Pad, 8" x 10", 20/BX, 320/CS
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48127 | Woven gauze roll/sheet | A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840155410480 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00816703028766 | GS1 | ||||
| Package | 00816703028773 | GS1 | Case | 320 | In Commercial Distribution |