AccessGUDID - DEVICE: ACell® (00386190001271)

GUDID

Device Identifier (DI) Information

Brand Name: ACell®
Version or Model: PFM0710
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PFM0710
Company Name: ACELL, INC.

Primary DI Number: 00386190001271
Issuing Agency: GS1
Commercial Distribution End Date: July 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 137258252 *Terms of Use

Device Description: Pelvic Floor Matrix 7 x 10 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61294	Pelvic organ prolapse/stress urinary incontinence surgical mesh	A sterile woven/knitted or porous material comprised of bioabsorbable, animal-derived collagen, intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor to surgically treat vaginal pelvic organ prolapse (POP) [including anterior, posterior, or apical prolapse repair], and may alternatively be implanted to support the urethra to treat female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It is typically available with various material attributes. Disposable devices associated with implantation (e.g., introducer needles) may be included.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 8b630044-8a15-45cb-b16d-e278667ce99e
Public Version Date: January 26, 2022
Public Version Number: 7
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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