ACell® PFM0505

GUDID 00386190001264

Pelvic Floor Matrix 5 x 5 cm

ACELL, INC.

Pelvic organ prolapse/stress urinary incontinence surgical mesh
Primary Device ID00386190001264
NIH Device Record Key9334ccf8-d861-449e-be8b-9aff2151807c
Commercial Distribution Discontinuation2018-07-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACell®
Version Model NumberPFM0505
Catalog NumberPFM0505
Company DUNS137258252
Company NameACELL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Length5 Centimeter
Length5 Centimeter
Width5 Centimeter
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Length5 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386190001264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXHMesh, surgical, collagen, plastic and reconstructive surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-29
Device Publish Date2017-01-20

On-Brand Devices [ACell®]

00386190001295Pelvic Floor Matrix 10 x 15 cm
00386190001288Pelvic Floor Matrix 9 x 12 cm
00386190001271Pelvic Floor Matrix 7 x 10 cm
00386190001264Pelvic Floor Matrix 5 x 5 cm
00386190001257Pelvic Floor Matrix 4 x 12 cm

Trademark Results [ACell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACELL
ACELL
78155813 2899342 Live/Registered
Acell, Inc.
2002-08-20
ACELL
ACELL
78155781 2899341 Live/Registered
Acell, Inc.
2002-08-20
ACELL
ACELL
77861361 not registered Dead/Abandoned
Fooyin University Hospital
2009-10-30

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