FDA UDI
In Commercial Distribution
🇺🇸 United States
Crosstex International
DI: 10732224000883
·
Model: ESCC
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
200
Basic Information
- Brand Name
- Crosstex International
- Primary DI
- 10732224000883
- Version / Model
- ESCC
- Catalog Number
- ESCC
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-08-19
- Public Version
- 2
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 34fadd7c-1b85-4499-aa40-e37e6d456d33
Device Description
Premium Cotton Filled Sponges, 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFN | COTTON, ROLL | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48131 | Non-woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30732224000887 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10732224000883 | GS1 | ||||
| Package | 50732224000881 | GS1 | 4 | In Commercial Distribution | ||
| Unit of Use | 00732224000886 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0167
- [email protected]