FDA UDI
In Commercial Distribution
🇺🇸 United States
CurPro Surgical Sponges All Gauze
DI: 00616784334516
·
Model: 3345
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- CurPro Surgical Sponges All Gauze
- Primary DI
- 00616784334516
- Version / Model
- 3345
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 5
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 0f91b3ca-46e4-47f1-89c8-9a1b5c774974
Device Description
4"x4", 12-ply (10.2cm x 10.2cm)
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 48134 | Woven gauze pad, non-antimicrobial | A non-medicated 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: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784334530 | GS1 | Case | 128 | In Commercial Distribution | |
| Primary | 00616784334516 | GS1 | ||||
| Unit of Use | 00810180840187 | GS1 |