ExoShape Teno

GUDID M970110001062004

EXOSHAPE-TENO Deployment Cartridge, 6mm x 20mm, Flat-Back

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device IDM970110001062004
NIH Device Record Keyf9f852cb-78a0-47dd-ab1d-d4fcd3ee7d3e
Commercial Distribution Discontinuation2023-06-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameExoShape Teno
Version Model Number1100-01-0620
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM970110001062004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number6
Public Version Date2023-06-27
Device Publish Date2015-09-22

On-Brand Devices [ExoShape Teno]

M970110001082006EXOSHAPE-TENO Deployment Cartridge, 8mm x 20mm, Flat-Back
M970110001092007EXOSHAPE-TENO Deployment Cartridge, 9mm x 20mm, Flat-Back
M970110001072005EXOSHAPE-TENO Deployment Cartridge, 7mm x 20mm, Flat-Back
M970110001062004EXOSHAPE-TENO Deployment Cartridge, 6mm x 20mm, Flat-Back

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