FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniTrustTM
DI: 00810572006351
·
Model: 9071-87
·
OMNI INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- OmniTrustTM
- Primary DI
- 00810572006351
- Version / Model
- 9071-87
- Catalog Number
- 9071-87
- Company Name
- OMNI INTERNATIONAL CORP.
- Labeler DUNS
- 079434709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- 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
- 85c5d784-850b-458f-99cf-acf513d9f4b5
Device Description
ABD Combine Dressing, Sterile, 8x7.5
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34084 | Wound compression dressing | A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50810572006356 | GS1 | Shipper Carton | 20 | In Commercial Distribution | |
| Primary | 00810572006351 | GS1 | ||||
| Unit of Use | 10810572006358 | GS1 |
Customer Contacts
- Phone
- +1(603)471-1499
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 7.5 | Inch |