FDA UDI
In Commercial Distribution
🇺🇸 United States
638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
DI: 00766588110141
·
Model: R211-014
·
Certified Safety Manufacturing, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
- Primary DI
- 00766588110141
- Version / Model
- R211-014
- Catalog Number
- R211-014
- Company Name
- Certified Safety Manufacturing, Inc.
- Labeler DUNS
- 788460483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-27
- Public Version
- 1
- Public Version Date
- 2023-02-06
- Public Version Status
- New
- Public Device Record Key
- 5cd780b9-6a2d-4d19-aedb-5349bddd6756
Device Description
638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EFQ | GAUZE/SPONGE, INTERNAL | Unknown | U |
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 |
|---|---|---|---|---|---|---|
| Primary | 00766588110141 | GS1 |
Customer Contacts
- Phone
- +1(816)483-9090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960615 | 000 |