FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330705940
·
Model: PCHSG66
·
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
- 10840330705940
- Version / Model
- PCHSG66
- Catalog Number
- PCHSG66
- 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
- 601a4354-e721-4dd7-a6f7-d6677370f745
Device Description
ProCure Healing Gauze Dressing with Gentle Silicone Adhesive Border 6"x6" 25ea/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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58749 | Dressing-fixation skin adhesive tape, silicone | A long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330705944 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 10840330705940 | GS1 | ||||
| Package | 50840330705948 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Inch | |
| Length | 6 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Should be stored in a dry, ventilated, non-corrosive gas environment, away from fire and flammable materials. Should be to prevent the weight, sun and rain dripping.