FDA UDI
In Commercial Distribution
🇺🇸 United States
Crosstex International
DI: 10732224001361
·
Model: ENACC
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
200
Basic Information
- Brand Name
- Crosstex International
- Primary DI
- 10732224001361
- Version / Model
- ENACC
- Catalog Number
- ENACC
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-08-25
- Public Version
- 3
- Public Version Date
- 2024-02-23
- Public Version Status
- Update
- Public Device Record Key
- 91632f8f-5f10-48c8-a71f-f326182941f7
Device Description
Advantage Plus Cotton Filled Sponges, Non-Sterile, 2" x 2"
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 48127 | Woven gauze roll/sheet | A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50732224001369 | GS1 | 4 | In Commercial Distribution | ||
| Package | 30732224001365 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10732224001361 | GS1 | ||||
| Unit of Use | 00732224001364 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0167
- [email protected]