DEVICE: Gentrix® (00386190001219)
Device Identifier (DI) Information
Gentrix®
MSPL0710
In Commercial Distribution
MSPL0710
ACELL, INC.
MSPL0710
In Commercial Distribution
MSPL0710
ACELL, INC.
Gentrix® Surgical Matrix Plus 7 x 10 cm
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
OXH | Mesh, surgical, collagen, plastic and reconstructive surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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 |
---|
Width: 7 Centimeter |
Length: 10 Centimeter |
Device Record Status
95d1b220-e44a-4c19-a934-5bff65704014
February 13, 2024
10
January 20, 2017
February 13, 2024
10
January 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)826-2926
customerservice@acell.com
customerservice@acell.com