BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

MatriStem

DI: 00386190000366 · Model: PSM0412 · ACELL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: MatriStem
Primary DI: 00386190000366
Version / Model: PSM0412
Catalog Number: PSM0412
Company Name: ACELL, INC.
Labeler DUNS: 137258252
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-01-10
Public Version: 8
Public Version Date: 2023-10-04
Public Version Status: Update
Public Device Record Key: c5473b0f-71f6-47a4-bc38-666c08cb78d6
Distribution End Date: 2018-12-31

Device Description

Surgical Matrix Thin 4 x 12 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: Labeling does not contain MRI Safety Information
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

GMDN Terms

Code	Name	Definition	Implantable	Status
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386190000366	GS1

Customer Contacts

Phone: +1(800)826-2926
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Rectangle device approximately 4 x 12 cm

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 15 – 35 Degrees Celsius