NanoHive IBFD TLIF01-11W-28L-12H

GUDID 00817493020305

TLIF, 11W, 28L, 12H, 0°

HD LIFESCIENCES LLC

Metallic spinal interbody fusion cage
Primary Device ID00817493020305
NIH Device Record Key327b7ff3-58fb-4daa-9e94-9f5453c39fbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoHive IBFD
Version Model Number03-A-0001-4012
Catalog NumberTLIF01-11W-28L-12H
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone844-943-5433
Emailinfo@hdlifesciences.com

Device Dimensions

Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter
Height12 Millimeter
Length28 Millimeter
Width11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100817493020305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2018-03-05

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°
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