131-01-26

GUDID 10885862022455

LINER PUSHER HEAD, 26mm

Exactech, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

Primary Device ID	10885862022455
NIH Device Record Key	096aa03b-d658-47e5-96b0-44d577e2b638
Commercial Distribution Status	In Commercial Distribution
Version Model Number	131-01-26
Catalog Number	131-01-26
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

Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter
Device Size Text, specify	0
Outer Diameter	26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862022455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173583

FDA Product Code

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