FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330702741
·
Model: PCSPNS01
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330702741
- Version / Model
- PCSPNS01
- Catalog Number
- PCSPNS01
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-08
- Public Version
- 1
- Public Version Date
- 2023-09-18
- Public Version Status
- New
- Public Device Record Key
- 2b34e046-34e7-4d10-8beb-7deed8142803
Device Description
No-Sting, Sting Free Skin Prep/Barrier Wipe, 1/pouch 50ea/bx 20bx/cs
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
- No
- 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 |
|---|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58978 | Synthetic-polymer liquid barrier dressing | A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330702745 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 10840330702741 | GS1 | ||||
| Package | 50840330702749 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 612-819-1635
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.96 | Inch | |
| Length | 2.48 | Inch |