FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330702376
·
Model: PCND44
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330702376
- Version / Model
- PCND44
- Catalog Number
- PCND44
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-11-27
- Public Version
- 1
- Public Version Date
- 2023-12-05
- Public Version Status
- New
- Public Device Record Key
- 8dc9bbc8-8ce0-4fc5-83d4-ef91b409b5b1
Device Description
Drain Sponges (Trache Gauze), Non-Woven, 4"x4" Sterile, 2ea/pk 25pk/bx 12bx/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
- 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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63661 | Non-woven gauze roll/sheet | A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330702370 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 10840330702376 | GS1 | ||||
| Package | 50840330702374 | GS1 | Case | 12 | In Commercial Distribution | |
| Unit of Use | 00840330702379 | GS1 |
Customer Contacts
- Phone
- 612-819-1635
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4 | Inch | |
| Length | 4 | Inch |