AccessGUDID - DEVICE: MatriStem (00386190000274)

GUDID

Device Identifier (DI) Information

Brand Name: MatriStem
Version or Model: SMRS0710
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SMRS0710
Company Name: ACELL, INC.

Primary DI Number: 00386190000274
Issuing Agency: GS1
Commercial Distribution End Date: February 03, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 137258252 *Terms of Use

Device Description: Surgical Matris RS 7 x 10 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Rectangle device approximately 7 x 10 cm

Device Record Status

Public Device Record Key: e7607750-f079-4844-8ede-6a89caafedc4
Public Version Date: October 04, 2023
Public Version Number: 11
DI Record Publish Date: January 10, 2017