SILICONE SHEETING

GUDID 00385640033343

SUMMIT MEDICAL, INC.

Silicone-sheet tissue reconstructive material, sterile
Primary Device ID00385640033343
NIH Device Record Key340b1e34-df6f-4fde-8f8e-230ae9755cdb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE SHEETING
Version Model NumberSP-66050
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640033343 [Primary]

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-05

On-Brand Devices [SILICONE SHEETING]

00385640033367SP-66150
00385640033350SP-66100
00385640033343SP-66050
00385640033336SP-66025
00385640033329SP-66012
00385640000116SP-65100
00385640000109SP-65000

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