201-61-11

GUDID 10885862044259

PATELLAR DRILL, 1 PEG, ZIMMER HUDSON, .352" DIAMETER

Exactech, Inc.

Fluted surgical drill bit, reusable
Primary Device ID10885862044259
NIH Device Record Key8bb7c2b0-f1ff-4e20-8a2c-b0b3bb173ac8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number201-61-11
Catalog Number201-61-11
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

Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch
Outer Diameter0.352 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862044259 [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

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

Moist Heat or Steam Sterilization

[10885862044259]

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

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