AlliedSil™ Sheeting 601-20

GUDID M724601201

Silicone Sheeting Reinforced

IMPLANTECH ASSOCIATES, INC.

Silicone-sheet tissue reconstructive material, non-sterile
Primary Device IDM724601201
NIH Device Record Keyf45b6b99-72c6-47d5-902b-8527cae6030f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlliedSil™ Sheeting
Version Model NumberSize: 203.2mm x 152.4mm x 0.508mm
Catalog Number601-20
Company DUNS784664955
Company NameIMPLANTECH 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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724601201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-14
Device Publish Date2015-09-24

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M724601201Silicone Sheeting Reinforced
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M724701201Silicone Sheeting Reinforced
M724701101Silicone Sheeting Reinforced
M724701071Silicone Sheeting Reinforced
M724700101Silicone Sheeting Non-Reinforced
M724601601Silicone Sheeting Reinforced
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M72423701302Silicone Sheeting Reinforced
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M72423700072Silicone Sheeting Non-Reinforced
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