FDA UDI
In Commercial Distribution
🇺🇸 United States
PrimaPad®
DI: 00809958087619
·
Model: 83323
·
Derma Sciences Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- PrimaPad®
- Primary DI
- 00809958087619
- Version / Model
- 83323
- Catalog Number
- DUP83323
- Company Name
- Derma Sciences Canada Inc
- Labeler DUNS
- 200564891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-10-23
- Public Version
- 4
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 0c04f778-8b7c-4dc9-8658-4a4da0ba3b4e
Device Description
2 in X 3 in non-adherent wound dressing. Sterile
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00809958087619 | GS1 | ||||
| Unit of Use | 00809958087602 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 in x 3 in | ||
| Device Size Text, specify | 5 cm X 7.5 cm |