01-019-01-0021

GUDID 10885862284426

21mm TAPERED REAMER REVISION STEM

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid
Primary Device ID10885862284426
NIH Device Record Key0c7cd206-f6bb-4eb1-a838-a0f11b8f739c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number01-019-01-0021
Catalog Number01-019-01-0021
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 Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862284426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

Moist Heat or Steam Sterilization


[10885862284426]

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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10885862653321 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 1.5
10885862653338 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 2.5
10885862653345 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 3.5

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