FDA UDI
In Commercial Distribution
🇺🇸 United States
Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing
DI: 00856040008762
·
Model: 5015G
·
ARGENTUM MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing
- Primary DI
- 00856040008762
- Version / Model
- 5015G
- Company Name
- ARGENTUM MEDICAL, LLC
- Labeler DUNS
- 091449079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-12
- Public Version
- 1
- Public Version Date
- 2023-06-20
- Public Version Status
- New
- Public Device Record Key
- b5283122-a5f5-4d39-b6c2-78b91b017136
Device Description
Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing cap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 00856040008786 | GS1 | CASE | 12 | In Commercial Distribution | |
| Primary | 00856040008762 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073547 | 000 |