DEVICE: Gentrix (00386190001523)
Device Identifier (DI) Information
Gentrix
PSMT1020
In Commercial Distribution
PSMT1020
ACELL, INC.
PSMT1020
In Commercial Distribution
PSMT1020
ACELL, INC.
Surgical Matrix Thick 10 x 20 cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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. |
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 |
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 |
---|
Length: 20 Centimeter |
Width: 10 Centimeter |
Device Record Status
a2fb9135-0c28-48ab-8db3-757f09153aa1
July 06, 2018
3
June 30, 2017
July 06, 2018
3
June 30, 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