Gentrix PSMT2030

GUDID 00386190001561

Surgical Matrix Thick 20 x 30 cm

ACELL, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable

Primary Device ID	00386190001561
NIH Device Record Key	dad075a8-cb69-46c4-8022-aefe529e5a53
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gentrix
Version Model Number	PSMT2030
Catalog Number	PSMT2030
Company DUNS	137258252
Company Name	ACELL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com
Phone	+1(800)826-2926
Email	customerservice@acell.com

Device Dimensions

Width	20 Centimeter
Width	20 Centimeter
Length	30 Centimeter
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Length	30 Centimeter
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Length	30 Centimeter
Width	20 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature
Special Storage Condition, Specify	Between 0 and 0 *Store in a clean, dry environment at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190001561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K041140

FDA Product Code

OXK	Mesh, surgical, collagen, large abdominal wall defects

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-18
Device Publish Date	2017-06-30

On-Brand Devices [Gentrix]

00386190001639	Surgical Matrix Extend 16 x 40 cm
00386190001622	Surgical Matrix Extend 16 x 30 cm
00386190001615	Surgical Matrix Extend 16 x 20 cm
00386190001608	Surgical Matrix Extend 10 x 20 cm
00386190001585	Surgical Matrix Thick 30 x 40 cm
00386190001578	Surgical Matrix Thick 30 x 30 cm
00386190001561	Surgical Matrix Thick 20 x 30 cm
00386190001554	Surgical Matrix Thick 20 x 25 cm
00386190001547	Surgical Matrix Thick 20 x 20 cm
00386190001530	Surgical Matrix Thick 16 x 20 cm
00386190001523	Surgical Matrix Thick 10 x 20 cm
00386190001387	Surgical Matrix 10 x 15 cm
00386190001370	Surgical Matrix 7 x 10 cm
00386190001363	Surgical Matrix 5 x 5 cm
00386190001356	Surgical Matrix Thin 10 x 15 cm
00386190001349	Surgical Matrix Thin 7 x 15 cm
00386190001332	Surgical Matrix Thin 7 x 10 cm
00386190001325	Surgical Matrix Thin 6 x 15 cm
00386190001318	Surgical Matrix Thin 5 x 5 cm
00386190001301	Surgical Matrix Thin 4 x 12 cm
00386190001240	Surgical Matrix Plus 10 x 15 cm
00386190001233	Surgical Matrix Plus 10 x 10 cm
00386190001226	Surgical Matrix Plus 5 x 7 cm
00386190001219	Surgical Matrix Plus 7 x 10 cm

Trademark Results [Gentrix]

Mark Image Registration \| Serial	Company Trademark Application Date
GENTRIX 86956739 5297343 Live/Registered	ACell, Inc. 2016-03-29
GENTRIX 86126669 not registered Dead/Abandoned	Gentrix 2013-11-22