FDA UDI
In Commercial Distribution
🇺🇸 United States
Solventum™ Nu-Gel™
DI: 00197998326967
·
Model: MNG425
·
Solventum Germany GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Solventum™ Nu-Gel™
- Primary DI
- 00197998326967
- Version / Model
- MNG425
- Catalog Number
- MNG425
- Company Name
- Solventum Germany GmbH
- Labeler DUNS
- 315518329
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-22
- Public Version
- 2
- Public Version Date
- 2026-04-30
- Public Version Status
- Update
- Public Device Record Key
- b9223d9c-ee52-4024-87ae-eea068e31e00
Device Description
Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/CAR, 4 CAR/CS, 24/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NAE | Dressing, wound, hydrogel without drug and/or biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00197998326981 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 00197998326967 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]