Durasorb Monofilament Mesh

GUDID 00860000875905

SURGICAL INNOVATION ASSOCIATES, INC.

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Primary Device ID00860000875905
NIH Device Record Keyb1578134-0431-4fe4-a40d-ef21ce311ca8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurasorb Monofilament Mesh
Version Model NumberPTM1025
Company DUNS117061618
Company NameSURGICAL INNOVATION ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health
Phone(224)-572-8633
Emailinfo@sia.health

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000875905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-25
Device Publish Date2019-12-17

On-Brand Devices [Durasorb Monofilament Mesh]

00860000875905PTM1025
00860000875943PTM2025
00860000875929PTM0616

Trademark Results [Durasorb Monofilament Mesh]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURASORB MONOFILAMENT MESH
DURASORB MONOFILAMENT MESH
88100341 not registered Live/Pending
Surgical Innovation Associates, Inc
2018-08-31
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