DEVICE: ACell® (00386190001264)

Device Identifier (DI) Information

ACell®
PFM0505
In Commercial Distribution
PFM0505
ACELL, INC.
00386190001264
GS1

1
137258252 *Terms of Use
Pelvic Floor Matrix 5 x 5 cm
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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
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.
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FDA Product Code

[?]
Product Code Product Code Name
OXH Mesh, surgical, collagen, plastic and reconstructive surgery
FTM Mesh, surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141084 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a clean, dry environment at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Width: 5 Centimeter
Length: 5 Centimeter
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Device Record Status

9334ccf8-d861-449e-be8b-9aff2151807c
July 06, 2018
3
January 20, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)826-2926
customerservice@acell.com
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