ExoShape

GUDID M9701101020000

ACL Procedure Pack, Sterile

Medshape, Inc.

Orthopaedic bone wire
Primary Device IDM9701101020000
NIH Device Record Key1fe9d257-c97c-484f-949a-d0db056bdd28
Commercial Distribution StatusIn Commercial Distribution
Brand NameExoShape
Version Model Number1101-02-000
Company DUNS601306413
Company NameMedshape, Inc.
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 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
HIBCCM9701101020000 [Primary]
HIBCCM97013000102404 [Direct Marking]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2015-12-15

On-Brand Devices [ExoShape]

M9701101020000ACL Procedure Pack, Sterile
M970110000093007EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled-Back
M970110000083006EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled-Back
M970110000073005EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled-Back
M970110000062800EXOSHAPE Deployment Cartridge, 6mm x 28mm, Angled-Back
M970110100123002EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled, Knurled
M970110100093008EXOSHAPE Deployment Cartridge, 9mm x 30mm, Angled, Knurled
M970110100083007EXOSHAPE Deployment Cartridge, 8mm x 30mm, Angled, Knurled
M970110100073006EXOSHAPE Deployment Cartridge, 7mm x 30mm, Angled, Knurled
M970110000123001EXOSHAPE Deployment Cartridge, 12mm x 30mm, Angled-Back

Trademark Results [ExoShape]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXOSHAPE
EXOSHAPE
85125012 3982761 Live/Registered
CONMED CORPORATION
2010-09-08

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