AccessGUDID - DEVICE: MatriStem (00386190000533)

GUDID

Device Identifier (DI) Information

Brand Name: MatriStem
Version or Model: PFM0912
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PFM0912
Company Name: ACELL, INC.

Primary DI Number: 00386190000533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137258252 *Terms of Use

Device Description: Pelvic Floor Matrix 9 x 12 cm

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Pelvic organ prolapse/stress urinary incontinence surgical mesh	A sterile woven/knitted or porous material comprised of bioabsorbable, animal-derived collagen, intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor to surgically treat vaginal pelvic organ prolapse (POP) [including anterior, posterior, or apical prolapse repair], and may alternatively be implanted to support the urethra to treat female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It is typically available with various material attributes. Disposable devices associated with implantation (e.g., introducer needles) may be included.

GMDN Preferred Term Name

GMDN Definition

Pelvic organ prolapse/stress urinary incontinence surgical mesh

A sterile woven/knitted or porous material comprised of bioabsorbable, animal-derived collagen, intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor to surgically treat vaginal pelvic organ prolapse (POP) [including anterior, posterior, or apical prolapse repair], and may alternatively be implanted to support the urethra to treat female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It is typically available with various material attributes. Disposable devices associated with implantation (e.g., introducer needles) may be included.

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141084	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
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Trapezodial device approximately 9 x 9 x 12 cm

Device Record Status

Public Device Record Key: 14adf3c3-458a-47b3-a18d-3895c66493ef
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 10, 2017