Drill Guide, DynaNail, 2.5 and 4mm

GUDID M97022000825400

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
Primary Device IDM97022000825400
NIH Device Record Key4c5d5fa3-f5e1-44bc-af15-f03f50b06470
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Guide, DynaNail, 2.5 and 4mm
Version Model Number2200-08-2540
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
HIBCCM97022000825400 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


[M97022000825400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-29
Device Publish Date2023-06-21

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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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