FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632069710
·
Model: GZ6004
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632069710
- Version / Model
- GZ6004
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-16
- Public Version
- 2
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 8f918d21-96d8-4a85-a53f-287ef63ffbc0
Device Description
Super Fluff Gauze Sponge Sterile 2/Pack 7.75 Inch X 8.75 Inch Large 100% Cotton Hypoallergenic 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
- 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 |
|---|---|---|---|---|
| 48134 | Woven gauze pad | A non-medicated 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: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632069714 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10885632069710 | GS1 | ||||
| Package | 20885632069717 | GS1 | 20 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 75 Percent (%) Relative Humidity