FDA UDI
In Commercial Distribution
🇺🇸 United States
NU-GEL®
DI: 15051978010012
·
Model: MNG425U
·
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NU-GEL®
- Primary DI
- 15051978010012
- Version / Model
- MNG425U
- Catalog Number
- MNG425U
- Company Name
- SYSTAGENIX WOUND MANAGEMENT, LIMITED
- Labeler DUNS
- 211352227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-24
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 26d402cb-b85d-47c6-904c-0b08ee3f61a9
Device Description
Hydrogel with Alginate
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
- No
- 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 | 25051978010019 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 15051978010012 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 25 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 25 Degrees Celsius