FDA.reportPublic FDA data

LUCENT XP

Primary DI
00840606163934
Brand
LUCENT XP
Company
SPINAL ELEMENTS, INC.
Model
11321-100-01
Device description
LUCENT® XP CURVED 12X27MM 15° IMPLANT CADDY - BASE
Published
2021-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606163934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606163934008406061639348406061639340840606163934

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606174800Primus66440-0002026-03-06
00840606187138Primus66900-0002026-02-27
00840606187145Primus66900-000-012026-02-27
00840606187152Primus66900-000-022026-02-27
00840606187169Primus66900-000-032026-02-27
00840606187176Primus66900-000-042026-02-27
00840606187268Primus66900-0302026-02-27
00840606187275Primus66900-030-012026-02-27
00840606187282Primus66900-030-022026-02-27
00840606187299Primus66900-030-032026-02-27
00840606187305Primus66900-030-042026-02-27
00840606187312Primus66900-030-052026-02-27
00840606187329Primus66900-030-062026-02-27
00840606187336Primus66900-030-072026-02-27
00840606187343Primus66900-030-082026-02-27
00840606187367Primus66900-030-092026-02-27
00840606185172Primus66430-0182026-01-23
00840606185189Primus66430-0242026-01-23
00840606185196Primus66430-1182026-01-23
00840606185202Primus66430-1242026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956257610CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956291812CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956321632CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956325487CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956354517CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956358904CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956369955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379190CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956382763CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
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10198956437869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442351CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442634CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956448339CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457980CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457997CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25