N/A NB-10162

GUDID 10850030914276

Long Pin Pouched

Microport Navibot International LLC

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

Primary Device ID	10850030914276
NIH Device Record Key	e2d3acd7-20aa-41c8-b9e5-b7ba3a26d2b2
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	10038-NB
Catalog Number	NB-10162
Company DUNS	118104014
Company Name	Microport Navibot International LLC
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	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030914279 [Primary]
GS1	10850030914276 [Package] Contains: 00850030914279 Package: Storage Box [3 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213873

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument