FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi-First Sterile Gauze Pads 3 x 3 (100 count)
DI: 00347682606336
·
Model: 60633
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medi-First Sterile Gauze Pads 3 x 3 (100 count)
- Primary DI
- 00347682606336
- Version / Model
- 60633
- Catalog Number
- 60633
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 3
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- 2a54d0eb-83e9-4cc5-9f4e-567c6849321d
Device Description
A sterile wound cover, gauze pad, intended to be used as an initial, short-term treatment after an injury. The device is typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad.
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 |
|---|---|---|---|---|
| 47011 | First aid absorbent pad/bandage | A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50347682606331 | GS1 | master case | 24 | In Commercial Distribution | |
| Primary | 00347682606336 | GS1 |
Customer Contacts
- Phone
- 1-800-634-7680
- [email protected]