01-007-04-4530

GUDID 10885862553003

ART DRILL DRVR, 4.5X30MM

Exactech, Inc.

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Primary Device ID	10885862553003
NIH Device Record Key	5226173a-79be-4f42-bd2a-2e2c9a1bdba2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	01-007-04-4530
Catalog Number	01-007-04-4530
Company DUNS	157565946
Company Name	Exactech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter
Length	30 Millimeter
Device Size Text, specify	0
Device Size Text, specify	0
Outer Diameter	4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862553003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141797

FDA Product Code

JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented