FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330700921
·
Model: PCTT20
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330700921
- Version / Model
- PCTT20
- Catalog Number
- PCTT20
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 2
- Public Version Date
- 2026-04-08
- Public Version Status
- Update
- Public Device Record Key
- b3167b86-1fde-4ad2-abea-46bdc31ce111
Device Description
Tape Transparent 2" Hypoallergenic Latex Free 6rl/bx 12bx/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
- Yes
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16866 | Dressing-fixation skin adhesive tape, non-silicone | A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330700925 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10840330700921 | GS1 | ||||
| Unit of Use | 00840330700924 | GS1 |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch |