Reusable Drill Guide Assembly, T-Shape, DynaClip, 26mm

GUDID M9703000050260

Medshape, Inc.

Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use Surgical drill guide, single-use
Primary Device IDM9703000050260
NIH Device Record Key800dd5a9-a685-44b9-8851-50bc1184f2f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Drill Guide Assembly, T-Shape, DynaClip, 26mm
Version Model Number3000-05-026
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9703000050260 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


[M9703000050260]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-23
Device Publish Date2023-08-15

Devices Manufactured by Medshape, Inc.

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M97031000400010 - Trajectory Wire, DynaFuse2024-04-09
M97031000700010 - Parallel Pin Guide, DynaFuse2024-04-09
M97031000900010 - Tissue Protector, DynaFuse2024-04-09
M97031001200010 - Tube Caddy, DynaFuse2024-04-09
M9703000050080 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 8mm2023-11-14
M9703000050100 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 10mm2023-11-14

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