209-71-18

GUDID 10885862056788

TIBIAL STEM EXTENSION DRILL, GUIDE, 18mm

Exactech, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID10885862056788
NIH Device Record Key26e4f1a6-f401-4d7b-9fda-a14c6682618a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number209-71-18
Catalog Number209-71-18
Company DUNS157565946
Company NameExactech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter
Lumen/Inner Diameter18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862056788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

[10885862056788]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

Devices Manufactured by Exactech, Inc.

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10885862623942 - EPIC2024-05-17 3.5mm LOCKING SCREW x 44mm
10885862623959 - EPIC2024-05-17 3.5mm LOCKING SCREW x 46mm
10885862623966 - EPIC2024-05-17 3.5mm LOCKING SCREW x 48mm
10885862623973 - EPIC2024-05-17 3.5mm LOCKING SCREW x 52mm
10885862623980 - EPIC2024-05-17 3.5mm LOCKING SCREW x 54mm
10885862623997 - EPIC2024-05-17 3.5mm LOCKING SCREW x 56mm
10885862624000 - EPIC2024-05-17 3.5mm LOCKING SCREW x 58mm
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