Lucent

GUDID 00840606121927

11MM CURVED SIZE

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00840606121927
NIH Device Record Keyc3bb8afc-7a9d-4834-ab28-df04207ed1c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucent
Version Model Number10007-011
Company DUNS610712213
Company NameSPINAL ELEMENTS, 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 Datetrue
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
GS100840606121927 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606121927]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Lucent]

08406061018039Lucent XP 10mm Shaft – Offset Inserter
08406061019548Retractor Light Cable
08406061019135LUCENT® L 22MM X 50MM X 12MM 6° CAGE, PC
08406061016752Lucent Retractor Light Guide
00840606116220Retractor Light Cable
00840606116213Lucent XP Expansion Driver
00840606116206Expandable Cage Offset Inserter Shaft - 12mm
00840606116190Lucent XP 10mm Shaft – Offset Inserter
00840606116121Lateral Implant Inserter
00840606114981Lucent L Retractor Light, 180mm
00840606114974Lucent L Retractor Light, 90mm
00840606114370LUCENT MIS TLIF FIBER OPTIC ASSEMBLY
00840606114363Lucent Retractor Light Guide
00840606114356BIFURCATED ACMI OUTPUT FIBER OPTIC TRANSITION CABLE
00840606100021Lucent XP 12mm Offset Inserter
00840606100014Lucent XP Offset Inserter
00840606154178MIS RIGHT ANGLED CURETTE, 5MM DEPTH MARKERS
00840606154161MIS LEFT ANGLED CURETTE, 5MM DEPTH MARKERS
00840606154154MIS STRAIGHT CURETTE, 5MM DEPTH MARKERS
00840606154147RIGHT ANGLED CURETTE DEPTH MARKERS
00840606154130LEFT ANGLED CURETTE DEPTH MARKERS
00840606154123STRAIGHT CURETTE DEPTH MARKERS
00840606114967Lucent L Short Bayoneted Bipolar Forceps
00840606114950Lucent L Long Bayoneted Biploar Forceps
00840606121651LUCENT® GUN TRAY LID
00840606121644LUCENT® CONTROLED DELIVERY GUN TRAY
008406061215388MM X 22MM 5° IMPLANT SUPER CADDY
0084060612152112MM X 27MM IMPLANT SUPER CADDY
0084060612151410MM X 22MM IMPLANT SUPER CADDY
0084060612150712MM X 27MM IMPLANT CADDY
0084060612149110MM X 22MM IMPLANT CADDY
00840606121484LUCENT® 10MM X 32MM 5° IMPLANT SUPER CADDY
00840606121477LUCENT® 10MM X 27MM 5° IMPLANT SUPER CADDY
00840606121460LUCENT® 8MM X 22MM 5° IMPLANT SUPER CADDY LID
00840606121453LUCENT® 8MM X 22MM 5° IMPLANT SUPER CADDY BASE LID
00840606121446LUCENT® 8MM X 22MM 5° IMPLANT SUPER CADDY BASE
00840606121439LUCENT® 12MM X 27MM 5° IMPLANT SUPER CADDY LID
00840606121422LUCENT® 12MM X 27MM 5° IMPLANT SUPER CADDY BASE
00840606121415LUCENT® 12MM X 27MM 5° IMPLANT SUPER CADDY
00840606121408LUCENT® 10MM X 22MM 5° IMPLANT SUPER CADDY LID
00840606121392LUCENT® 10MM X 22MM 5° IMPLANT SUPER CADDY BASE
00840606121385LUCENT® 10MM X 22MM 5° IMPLANT SUPER CADDY
00840606121378LUCENT® IMPLANTS & INSTRUMENTS, TRAY 2 LID
00840606121361LUCENT® 8MM X 22MM 5° IMPLANT SUPER CADDY
00840606121354LUCENT® INSTURMENT TRAY 2, INSERT
00840606121347LUCENT® 12MM X 27MM IMPLANT SUPER CADDY
00840606121330LUCENT® INSTURMENT TRAY 2, BASE
00840606121323LUCENT® 10MM X 22MM IMPLANT SUPER CADDY
00840606121316LUCENT® 12MM X 27MM IMPLANT CADDY
00840606121309LUCENT® 10MM X 22MM IMPLANT CADDY

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