FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196740123
·
Model: PRM21454
·
MEDLINE INDUSTRIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196740123
- Version / Model
- PRM21454
- Catalog Number
- PRM21454
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-16
- Public Version
- 1
- Public Version Date
- 2022-11-24
- Public Version Status
- New
- Public Device Record Key
- 2e0d63ff-e76b-4e61-8555-52f3cb605a38
Device Description
PAD,ABDOMINAL,8"X10",ST,LF
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
- Yes
- 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
- 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 |
| GDY | Gauze/sponge, internal, x-ray detectable | General, Plastic Surgery | 878.4450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30080196740127 | GS1 | BOX | 16 | In Commercial Distribution | |
| Primary | 10080196740123 | GS1 | ||||
| Package | 40080196740124 | GS1 | CASE | 320 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]