Precision Screw CRY01-H3-1E

GUDID 09351290000074

CRYPTYCH PTY LTD

Spinal bone screw, non-bioabsorbable
Primary Device ID09351290000074
NIH Device Record Keyf9e400c3-967d-4811-8aef-827b5dbfc483
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Screw
Version Model NumberCRY01-H3-1E
Catalog NumberCRY01-H3-1E
Company DUNS742846228
Company NameCRYPTYCH PTY LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109351290000074 [Primary]
GS119351290000071 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-09
Device Publish Date2016-10-18

On-Brand Devices [Precision Screw]

09351290000081CRY01-H4-1E
09351290000074CRY01-H3-1E

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