Drill, variable size, DynaClip staple, 2.0mm

GUDID M970ED108020200

Medshape, Inc.

Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable
Primary Device IDM970ED108020200
NIH Device Record Key30e8874b-612f-4f3d-b066-a03f9a879f80
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill, variable size, DynaClip staple, 2.0mm
Version Model NumberED-10802.020
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
HIBCCM970ED108020200 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

Moist Heat or Steam Sterilization


[M970ED108020200]

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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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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