InFrame Instrument Kit EXINF912000

GUDID B487EXINF9120000

InFrame sterile instrument kit. The kit contains two step guide wires, one cannulated drill, one depth gauge

Exsomed Corporation

Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use Surgical depth gauge, single-use
Primary Device IDB487EXINF9120000
NIH Device Record Keyabdfeb1f-f70b-4ab1-af5d-10c98abee077
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFrame Instrument Kit
Version Model NumberEXINF912000
Catalog NumberEXINF912000
Company DUNS116722111
Company NameExsomed Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB487EXINF9120000 [Primary]

FDA Product Code

HXIPasser, Wire, Orthopedic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-08
Device Publish Date2021-08-31

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