141-01-22

GUDID 10885862026118

LINER DRIVER HEAD, 22mm

Exactech, Inc.

Orthopaedic implant impactor
Primary Device ID10885862026118
NIH Device Record Key55090dc2-d162-404c-b508-9f5952cf1a5b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number141-01-22
Catalog Number141-01-22
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 Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0
Outer Diameter22 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862026118 [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

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

Moist Heat or Steam Sterilization

[10885862026118]

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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