FDA UDI
In Commercial Distribution
🇺🇸 United States
NewGel+ Silicone Gel Sheeting
DI: 00816465021036
·
Model: NG-170
·
Newmedical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NewGel+ Silicone Gel Sheeting
- Primary DI
- 00816465021036
- Version / Model
- NG-170
- Company Name
- Newmedical Technology, Inc.
- Labeler DUNS
- 787828669
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-07
- Public Version
- 1
- Public Version Date
- 2025-08-15
- Public Version Status
- New
- Public Device Record Key
- b0cf548e-77dd-4086-a6fb-c40281f8513a
Device Description
NG-170 NewGel+ Beige Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44898 | Scar-management dressing, reusable | A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816465021036 | GS1 |
Customer Contacts
- Phone
- 847-412-1000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041704 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 80 Degrees Fahrenheit