Parietene DS PPDS1510

GUDID 10884521553453

Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking

SOFRADIM PRODUCTION

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Primary Device ID	10884521553453
NIH Device Record Key	62d8b661-a6f0-481d-851b-d20bc45bffd8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Parietene DS
Version Model Number	PPDS1510
Catalog Number	PPDS1510
Company DUNS	576342646
Company Name	SOFRADIM PRODUCTION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
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
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

Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 Centimeter
Width	15 Centimeter
Length	10 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;

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521553453 [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	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-10-21
Device Publish Date	2017-12-15

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