FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330703335
·
Model: PCHP3001
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330703335
- Version / Model
- PCHP3001
- Catalog Number
- PCHP3001
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 1
- Public Version Date
- 2023-12-06
- Public Version Status
- New
- Public Device Record Key
- 4bef2aa7-ae38-42b0-ac01-e6356c3737b2
Device Description
ProCure - Petrolatum Gauze Dressing 1"x8" 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
- 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 |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48132 | Petrolatum woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330703339 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 10840330703335 | GS1 | ||||
| Package | 50840330703333 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 612-819-1635
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 1 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Avoid Freezing & Direct Sunlight