213-64-41

GUDID 10885862059864

AXIAL PATELLA REAMER 41MM STANDARD BLADE

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable
Primary Device ID10885862059864
NIH Device Record Key0b82eabc-dca8-41d1-9d35-ce637943c7c5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number213-64-41
Catalog Number213-64-41
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter
Width41 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862059864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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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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