AccessGUDID - DEVICE: DynaMatrix Plus (00827002568990)

GUDID

Device Identifier (DI) Information

Brand Name: DynaMatrix Plus
Version or Model: G56899
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10.501.1030
Company Name: COOK BIOTECH INCORPORATED

Primary DI Number: 00827002568990
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945385862 *Terms of Use

Device Description: DynaMatrix Plus Extracellular Membrane

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPL	Barrier, animal source, intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082058	000
K161762	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
Special Storage Condition, Specify: Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 74257dd0-f8ed-4258-a147-9fdd1c1eb373
Public Version Date: February 19, 2025
Public Version Number: 9
DI Record Publish Date: November 03, 2015