20-8000-000-03

GUDID 00889024304208

Orthosoft Inc

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

Primary Device ID	00889024304208
NIH Device Record Key	d5ebd09b-b598-4def-ad22-35a86f913cdd
Commercial Distribution Status	In Commercial Distribution
Version Model Number	20-8000-000-03
Catalog Number	20-8000-000-03
Company DUNS	205670032
Company Name	Orthosoft Inc
Device Count	12
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	true
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

Customer Support Contacts

Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com
Phone	1(800)-348-2759
Email	zimmer.consumerrelations@zimmer.com

Device Dimensions

Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter
Outer Diameter	3.2 Millimeter
Length	80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024304208 [Primary]
GS1	00889024466319 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030827

FDA Product Code

HAW	Neurological Stereotaxic Instrument