FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330700792
·
Model: PCBASS
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330700792
- Version / Model
- PCBASS
- Catalog Number
- PCBASS
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- 9dc4eccf-5b9d-4d39-ab9a-e312b9debeeb
Device Description
Band Aids Sheer Spots 7/8" - 100ea/bx 24bx/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 |
|---|---|---|---|---|
| 47011 | First aid absorbent pad/bandage | A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330700796 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 10840330700792 | GS1 | ||||
| Unit of Use | 00840330700795 | GS1 |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | .875 | Inch |