FDA UDI
In Commercial Distribution
🇺🇸 United States
Vitale
DI: B492238440
·
Model: 23844
·
CELLERA LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Vitale
- Primary DI
- B492238440
- Version / Model
- 23844
- Catalog Number
- 23844
- Company Name
- CELLERA LLC
- Labeler DUNS
- 960091929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-13
- Public Version
- 3
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 6435e368-7a8a-40c0-a18a-20f252016702
Device Description
Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
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
- 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 W/Out 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 |
|---|---|---|---|---|---|---|
| Primary | B492238440 | HIBCC | ||||
| Package | B492238441 | HIBCC | box | 10 | In Commercial Distribution | |
| Package | B492238442 | HIBCC | case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 8008922391
- [email protected]