DEVICE: Vitale (B492202800)
Device Identifier (DI) Information
Vitale
20280
Not in Commercial Distribution
20280
CELLERA LLC
20280
Not in Commercial Distribution
20280
CELLERA LLC
Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 44970 | Exudate-absorbent dressing, non-gel, non-antimicrobial |
A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NAC | Dressing,Wound,Hydrophilic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c8d7b262-4f24-460d-a1cc-984b848ffa5d
June 22, 2021
6
June 26, 2017
June 22, 2021
6
June 26, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| B492202803 | 10 | B492202801 | 2018-07-31 | Not in Commercial Distribution | case |
| B492202801 | 10 | B492202800 | 2018-07-31 | Not in Commercial Distribution | box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-892-2391
sales@cellerallc.com
sales@cellerallc.com