FDA.report

Lucent L

Primary DI
00840606156141
Brand
Lucent L
Company
SPINAL ELEMENTS, INC.
Model
12242-810
Device description
LUCENT® L TRIAL 22MM x 10MM 18°
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840606156141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606156141008406061561418406061561410840606156141

GMDN Terms

TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods

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

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