FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330704943
·
Model: PCHH3304
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330704943
- Version / Model
- PCHH3304
- Catalog Number
- PCHH3304
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- 7a8faa9c-623e-4435-ac48-8ed52085e248
Device Description
ProCure Hydrogel Impregnated Dressing 4"x4" - 15ea/bx 20bx/cs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330704947 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 10840330704943 | GS1 | ||||
| Package | 50840330704941 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter | |
| Width | 10 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Keep product dry and away from direct sunlight.