The Stork OTC

GUDID 00810396020304

Stork OTC, General, S-Box

STORK IB2C, INC., THE

Conceptive cervical cap, single-use Conceptive cervical cap, single-use
Primary Device ID00810396020304
NIH Device Record Keyd6f037ab-6445-47cf-b4e8-8c04859734ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Stork OTC
Version Model Number1000-030
Company DUNS968804521
Company NameSTORK IB2C, INC., THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone412-200-7996
Emailinfo@rinovum.com
Phone412-200-7996
Emailinfo@rinovum.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810396020304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBBKit, Conception-Assist, Home Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-11

On-Brand Devices [The Stork OTC]

00810396020335The Stork, Merck Femibion
00810396020311Stork OTC, Walgreens, S-Box
00810396020304Stork OTC, General, S-Box
00810396020199The Stork OTC, General
00810396020090The Stork, UK
00810396020083The Stork OTC, CVS

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