N/A NB-10163

GUDID 10850030914283

Nail 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 ID10850030914283
NIH Device Record Key338e1b0a-5416-4b40-9a2e-f4f94807a7b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number10040-NB
Catalog NumberNB-10163
Company DUNS118104014
Company NameMicroport Navibot International LLC
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 Usetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100850030914286 [Primary]
GS110850030914283 [Package]
Contains: 00850030914286
Package: Storage Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


[10850030914283]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-25
Device Publish Date2023-01-18

On-Brand Devices [N/A]

00850030914064Tunnel Guide
00850030914040Fixation Component
10850030914283Nail Pouched
10850030914276Long Pin Pouched
10850030914269Standard Pin Pouched
10850030914146Knee Kit Sterilization Tray
00850030914118Osteotomy Probe Probe L Type

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