AccessGUDID - DEVICE: Vitale (00850005565185)

GUDID

Device Identifier (DI) Information

Brand Name: Vitale
Version or Model: 22000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22000
Company Name: CELLERA LLC

Primary DI Number: 00850005565185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960091929 *Terms of Use

Device Description: Vitale Collagen Powder, 1 gram/packet, 10 packets/box, 10 boxes/case, 8 cases/overpack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Dressing, Wound, Collagen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030921	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 976c75ad-b7a4-4deb-b7e8-a5bc3f24cb2e
Public Version Date: July 21, 2025
Public Version Number: 5
DI Record Publish Date: May 24, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00850005565208	8	10850005565199	2023-03-28	Not in Commercial Distribution	overpack
10850005565199	10	00850005565192		In Commercial Distribution	case
00850005565192	10	00850005565185		In Commercial Distribution	box
20850005565196	8	10850005565199		In Commercial Distribution	overpack