NanoHive IBFD

GUDID 00817493021067

Lumbar Inserter, Long, Stylet

HD LIFESCIENCES LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00817493021067
NIH Device Record Keybb3e51df-5f47-4152-ac14-56b9088322fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoHive IBFD
Version Model NumberL-C-0001-01
Company DUNS080469093
Company NameHD LIFESCIENCES 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 Usefalse
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

Customer Support Contacts

Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com
Phone844-943-5433
Emailinfo@hdlifesciences.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817493021067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

[00817493021067]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2018-08-02

On-Brand Devices [NanoHive IBFD]

00817493021098Lumbar Inserter, Short, Stylet
00817493021081Lumbar Inserter, Short, Shaft
00817493021074Lumbar Inserter, Long, Shaft
00817493021067Lumbar Inserter, Long, Stylet
00817493021043TLIF, 09W, 26L, 14H, 8°
00817493021036TLIF, 09W, 26L, 13H, 8°
00817493021029TLIF, 09W, 26L, 12H, 8°
00817493021012TLIF, 09W, 26L, 11H, 8°
00817493021005TLIF, 09W, 26L, 10H, 8°
00817493020992TLIF, 09W, 26L, 09H, 8°
00817493020985ALIF, 38W, 26L, 19H, 22°
00817493020978ALIF, 38W, 26L, 17H, 22°
00817493020961ALIF, 38W, 26L, 15H, 22°
00817493020954ALIF, 38W, 26L, 13H, 22°
00817493020879TLIF, 10W, 30L, 15H, 10°
00817493020862TLIF, 10W, 30L, 14H, 10°
00817493020855TLIF, 10W, 30L, 13H, 10°
00817493020848TLIF, 10W, 30L, 12H, 10°
00817493020831TLIF, 10W, 30L, 11H, 10°
00817493020824TLIF, 10W, 30L, 10H, 10°
00817493020718ALIF, 38W, 26L, 19H, 15°
00817493020701ALIF, 38W, 26L, 17H, 15°
00817493020695ALIF, 38W, 26L, 15H, 15°
00817493020688ALIF, 38W, 26L, 13H, 15°
00817493020671ALIF, 38W, 26L, 11H, 15°
00817493020664ALIF, 38W, 26L, 19H, 8°
00817493020657ALIF, 38W, 26L, 17H, 8°
00817493020640ALIF, 38W, 26L, 15H, 8°
00817493020633ALIF, 38W, 26L, 13H, 8°
00817493020626ALIF, 38W, 26L, 11H, 8°
00817493020619ALIF, 32W, 26L, 19H, 15°
00817493020602ALIF, 32W, 26L, 17H, 15°
00817493020596ALIF, 32W, 26L, 15H, 15°
00817493020589ALIF, 32W, 26L, 13H, 15°
00817493020572ALIF, 32W, 26L, 11H, 15°
00817493020565ALIF, 32W, 26L, 19H, 8°
00817493020558ALIF, 32W, 26L, 17H, 8°
00817493020541ALIF, 32W, 26L, 15H, 8°
00817493020534ALIF, 32W, 26L, 13H, 8°
00817493020527ALIF, 32W, 26L, 11H, 8°
00817493020336TLIF, 11W, 28L, 15H, 0°
00817493020329TLIF, 11W, 28L, 14H, 0°
00817493020312TLIF, 11W, 28L, 13H, 0°
00817493020305TLIF, 11W, 28L, 12H, 0°
00817493020299TLIF, 11W, 28L, 11H, 0°
00817493020282TLIF, 11W, 28L, 10H, 0°
00817493020275TLIF, 11W, 28L, 09H, 0°
00817493020268TLIF, 11W, 28L, 08H, 0°
00817493020251TLIF, 11W, 28L, 07H, 0°
00817493020244TLIF, 09W, 26L, 12H, 8°
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.