NuTech Spine 00.801.004

GUDID B946008010040

Handle-Teardrop, Cannulated, LG Hudson (Fixed)

NUTECH SPINE, INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device IDB946008010040
NIH Device Record Key44ceb07c-b635-4c45-8bab-c37b350d837d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuTech Spine
Version Model NumberIR
Catalog Number00.801.004
Company DUNS080867996
Company NameNUTECH SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB946008010040 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


[B946008010040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

Devices Manufactured by NUTECH SPINE, INC.

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B946008010040 - NuTech Spine2020-10-02Handle-Teardrop, Cannulated, LG Hudson (Fixed)
B946008010040 - NuTech Spine2020-10-02 Handle-Teardrop, Cannulated, LG Hudson (Fixed)
B946014000010 - NuFix2020-10-02 4.5mm NuFix Drill Bit
B946021000010 - NuFix II2020-10-02 NuFix II Go/No-Go Gage
B946024000010 - NuFix II2020-10-02 NuFix II Drill, 4.5mm
B946024000030 - NuFix II2020-10-02 NuFix II Broach
B946024000040 - NuFix II2020-10-02 NuFix II Drill, 4.5mm - Tapered

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