FDA UDI
In Commercial Distribution
🇺🇸 United States
Calcium Alginate Ag (Silver) Dressing (4x8 in)
DI: 00361554000978
·
Model: GEN-13482
·
Gentell, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- Calcium Alginate Ag (Silver) Dressing (4x8 in)
- Primary DI
- 00361554000978
- Version / Model
- GEN-13482
- Catalog Number
- GEN-13482
- Company Name
- Gentell, LLC
- Labeler DUNS
- 170967876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-02-18
- Public Version
- 1
- Public Version Date
- 2025-02-26
- Public Version Status
- New
- Public Device Record Key
- 2e37fd7b-f011-44ae-92e3-9e5cf0b3d9f6
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47474 | Exudate-absorbent dressing, hydrophilic-gel, antimicrobial | A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00361554000985 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00361554000978 | GS1 | ||||
| Unit of Use | 00361554000961 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120181 | 000 |