FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 20885632070201
·
Model: GZ5502
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 20885632070201
- Version / Model
- GZ5502
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-16
- Public Version
- 1
- Public Version Date
- 2020-09-24
- Public Version Status
- New
- Public Device Record Key
- 6b47df21-6b7a-401d-951e-c6790faf3af7
Device Description
Fluff Gauze Sponge Bulk Non-Sterile 4 Inch X 4 Inch Small 16-Ply 100% Cotton Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
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
- 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 |
|---|---|---|---|---|
| 48133 | Woven gauze pad, non-sterile | A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632070208 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 20885632070201 | GS1 | ||||
| Unit of Use | 10885632070204 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 75 Percent (%) Relative Humidity