FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniTrustTM
DI: 00810572006078
·
Model: 9012-44
·
OMNI INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- OmniTrustTM
- Primary DI
- 00810572006078
- Version / Model
- 9012-44
- Catalog Number
- 9012-44
- Company Name
- OMNI INTERNATIONAL CORP.
- Labeler DUNS
- 079434709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2019-08-27
- Public Version
- 1
- Public Version Date
- 2019-09-04
- Public Version Status
- New
- Public Device Record Key
- f4d1c607-918a-42ba-ba16-c565cefbcdbe
Device Description
Gauze Sponge, Non-Sterile, 4x4, 12 Ply
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
- Yes
- 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 | 50810572006073 | GS1 | Shipper Carton | 10 | In Commercial Distribution | |
| Primary | 00810572006078 | GS1 | ||||
| Unit of Use | 10810572006075 | GS1 |
Customer Contacts
- Phone
- +1(603)471-1499
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Inch | |
| Length | 4 | Inch |