Parietene DS PPDS2520

GUDID 10884521795419

Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, composite-polymer

Primary Device ID	10884521795419
NIH Device Record Key	ffbe7fe6-f200-464e-93e1-b270de00749a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Parietene DS
Version Model Number	PPDS2520
Catalog Number	PPDS2520
Company DUNS	576342646
Company Name	SOFRADIM PRODUCTION
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	false
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(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com

Device Dimensions

Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Device Size Text, specify	0
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter
Length	20 Centimeter
Width	25 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;
Special Storage Condition, Specify	Between 0 and 0 *No;

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521795419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163212

FDA Product Code

FTL	Mesh, surgical, polymeric

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-02-03
Device Publish Date	2020-01-26

On-Brand Devices [Parietene DS]

10884521553507	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521795426	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521795419	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521795402	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521795396	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521795389	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521784130	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521784120	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521784116	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521784106	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521784090	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521784083	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521553559	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521553542	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521553535	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
20884521553528	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553491	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553484	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553477	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553460	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553453	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
10884521553446	Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking