PRO-OPTIONS

GUDID 07350111280260

Pro-Options AB

Rubber dam, Hevea-latex
Primary Device ID07350111280260
NIH Device Record Keyd056957e-454f-4c9a-aa99-47efd485084f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO-OPTIONS
Version Model Number8060
Company DUNS554775309
Company NamePro-Options AB
Device Count36
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 Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350111280000 [Primary]
GS107350111280260 [Unit of Use]

FDA Product Code

EIEDam, Rubber

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

On-Brand Devices [PRO-OPTIONS]

0735011128004805054
0735011128003105053
073501112802468080
073501112802538070
073501112802608060

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