N/A 161-10-17

GUDID 10885862661142

Reamer, Straight

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid
Primary Device ID10885862661142
NIH Device Record Keyc9df6259-fa58-489c-bfd1-217fcd600580
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number161-10-17
Catalog Number161-10-17
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 Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter
Outer Diameter17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862661142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


[10885862661142]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-27
Device Publish Date2026-03-19

On-Brand Devices [N/A]

10885862663238Osteotome, Box
10885862663221Femoral Head Impactor
10885862663214Femoral Stem Extractor, Universal
10885862661555Driver, Hex, Universal
10885862661470Removal Tool, Constraining Ring
10885862661463C Adaptor, Liner Driver, Keyed
10885862661456Adaptor, Liner Driver, Keyed
10885862661449Depth Gauge, Assembly
10885862661432Handle, Ratcheting
10885862661296Osteotomy
10885862661289Broach Handle
10885862661272Stem Extractor
10885862661265Broach
10885862661258Assembly, Broach Handle
10885862661241Inserter, Stem
10885862661234Retractor, Acetabular
10885862661227Osteotomy Guide
10885862661173Reamer, Straight
10885862661166Reamer, Straight
10885862661159Reamer, Straight
10885862661142Reamer, Straight
10885862661135Reamer, Straight
10885862661128Reamer, Straight
10885862661111Reamer, Straight
10885862661104Reamer, Straight
10885862661098Reamer, Straight
10885862661081Reamer, Straight
10885862661074Reamer, Straight
10885862661067Reamer, Straight
10885862661050Reamer, Straight
10885862661043Reamer, Straight
10885862661036Reamer, Straight
10885862661012Reamer, Straight
10885862661005Reamer, Straight
10885862660992Reamer, Straight
10885862660985Reamer, Straight
10885862660978Reamer, Straight
10885862660718Broach Handle, Version Assist Bar
10885862660688Pointer Assembly, Osteotomy Guide
10885862660664Liner Driver Head
10885862660657Liner Driver Head
10885862660640Liner Driver Head
10885862660633Liner Driver Head
10885862660596Liner Driver Head, Impactor, Adaptor
10885862660589Impactor Alignment Guide, Cup
10885862660473Trunnion Version Guide
10885862660466Trail, Extractor
10885862660459Revision Stem Reamer
10885862660442Revision Stem Reamer
10885862660435Revision Stem Reamer

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