ACell® PFM1015

GUDID 00386190001295

Pelvic Floor Matrix 10 x 15 cm

ACELL, INC.

Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh Pelvic organ prolapse/stress urinary incontinence surgical mesh

• Primary Device ID: 00386190001295
• NIH Device Record Key: d75dd1f3-67d7-468a-b34d-a69d4ee7e8e0
• Commercial Distribution Discontinuation: 2018-07-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACell®
• Version Model Number: PFM1015
• Catalog Number: PFM1015
• 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

Device Dimensions

• Width: 10 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190001295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141084

FDA Product Code

• FTM: Mesh, surgical

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: 2018-10-29
• Device Publish Date: 2017-01-20

On-Brand Devices [ACell®]

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