FDA.reportPublic FDA data

LUCENT XP

Primary DI
00840606154987
Brand
LUCENT XP
Company
SPINAL ELEMENTS, INC.
Model
11364-000-02
Device description
LUCENT XP® 10X32MM 10-15° CADDY LID
Published
2020-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840606154987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606154987008406061549878406061549870840606154987

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10193489213027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489213911Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489214130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214406Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214499Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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10193489216165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217117Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08