Gentrix EXT1620

GUDID 00386190001615

Surgical Matrix Extend 16 x 20 cm

ACELL, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable

Primary Device ID	00386190001615
NIH Device Record Key	f6003b0f-fe0c-424f-ba80-9fa03b1e2d19
Commercial Distribution Discontinuation	2018-01-04
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Gentrix
Version Model Number	EXT1620
Catalog Number	EXT1620
Company DUNS	137258252
Company Name	ACELL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
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

Device Dimensions

Length	20 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
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Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	20 Centimeter
Width	16 Centimeter
Length	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190001615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170763

FDA Product Code

OXH	Mesh, surgical, collagen, plastic and reconstructive surgery

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-09-25

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