FDA UDI
In Commercial Distribution
🇺🇸 United States
Silverband
DI: 07290019556008
·
Model: 28.35 gram
·
NSBT (Nano Silver Biotech Medical) Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Silverband
- Primary DI
- 07290019556008
- Version / Model
- 28.35 gram
- Company Name
- NSBT (Nano Silver Biotech Medical) Ltd.
- Labeler DUNS
- 600139914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-08
- Public Version
- 1
- Public Version Date
- 2023-12-18
- Public Version Status
- New
- Public Device Record Key
- 0bea113a-2751-4df0-920d-ea201b1f1d06
Device Description
Silverband Wound Dressing Gel, 28.35 gram
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59522 | Wound hydrogel dressing, antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019556008 | GS1 | ||||
| Package | 27290019556002 | GS1 | box | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 8017638000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140483 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 28 | Gram |