AccessGUDID - DEVICE: Gentrix (00386190001523)

GUDID

Device Identifier (DI) Information

Brand Name: Gentrix
Version or Model: PSMT1020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSMT1020
Company Name: ACELL, INC.

Primary DI Number: 00386190001523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137258252 *Terms of Use

Device Description: Surgical Matrix Thick 10 x 20 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
Multi-purpose surgical mesh, collagen, bioabsorbable	A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

GMDN Preferred Term Name

GMDN Definition

Multi-purpose surgical mesh, collagen, bioabsorbable

A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

FDA Product Code

[?]

Product Code	Product Code Name
OXK	Mesh, surgical, collagen, large abdominal wall defects
OXH	Mesh, surgical, collagen, plastic and reconstructive surgery
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041140	000
K170763	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, dry environment at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 20 Centimeter
Width: 10 Centimeter

Device Record Status

Public Device Record Key: a2fb9135-0c28-48ab-8db3-757f09153aa1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 30, 2017