ACell®

Basic Information

• Brand Name: ACell®
• Primary DI: 00386190001271
• Version / Model: PFM0710
• Catalog Number: PFM0710
• Company Name: ACELL, INC.
• Labeler DUNS: 137258252
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 7
• Public Version Date: 2022-01-26
• Public Version Status: Update
• Public Device Record Key: 8b630044-8a15-45cb-b16d-e278667ce99e
• Distribution End Date: 2018-07-05

Device Description

Pelvic Floor Matrix 7 x 10 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTM	Mesh, surgical	General, Plastic Surgery	878.3300	2
OXH	Mesh, surgical, collagen, plastic and reconstructive surgery	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386190001271	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	7	Centimeter
Length	10	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry environment at room temperature