FDA UDI
In Commercial Distribution
🇺🇸 United States
CurPro Combine Pads
DI: 00616784351230
·
Model: 3512
·
Dynarex Corporation
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
576
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Basic Information
- Brand Name
- CurPro Combine Pads
- Primary DI
- 00616784351230
- Version / Model
- 3512
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 576
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 3
- Public Version Date
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- 71d9e88d-77cc-4808-8300-72a52143c18a
Device Description
Non-Sterile, 8"x7 1/2"
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
- 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
- No
- 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 |
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58805 | Absorbent wound compression pad | A rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00616784351230 | GS1 | ||||
| Unit of Use | 00616784351223 | GS1 |