FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi-First Roller Gauze 2" x 4 yards
DI: 00347682689995
·
Model: 68999
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medi-First Roller Gauze 2" x 4 yards
- Primary DI
- 00347682689995
- Version / Model
- 68999
- Catalog Number
- 68999
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-19
- Public Version
- 1
- Public Version Date
- 2019-07-29
- Public Version Status
- New
- Public Device Record Key
- 94fd10e8-57da-4c3d-8a98-6f34a26d0089
Device Description
A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (gauze), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 48126 | Woven gauze roll, non-sterile | A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50347682689990 | GS1 | master case | 200 | In Commercial Distribution | |
| Primary | 00347682689995 | GS1 |
Customer Contacts
- Phone
- 1-800-634-7680
- [email protected]