ITN Implant EXITN924545

GUDID B487EXITN9245450

ITN Implant is a stainless steel bone screw

EXSOMED CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband
Primary Device IDB487EXITN9245450
NIH Device Record Keyc809836e-2438-4a5b-bdbf-f62b42e8d9ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameITN Implant
Version Model NumberEXITN924545
Catalog NumberEXITN924545
Company DUNS116722111
Company NameEXSOMED CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB487EXITN9245450 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-16
Device Publish Date2018-04-06

On-Brand Devices [ITN Implant]

B487EXITN9245750ITN Implant is a stainless steel bone screw
B487EXITN9245650ITN Implant is a stainless steel bone screw
B487EXITN9245550ITN Implant is a stainless steel bone screw
B487EXITN9245500ITN Implant is a stainless steel bone screw
B487EXITN9245450ITN Implant is a stainless steel bone screw
B487EXITN9245400ITN Implant is a stainless steel bone screw
B487EXITN9245350ITN Implant is a stainless steel bone screw

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