FDA.report

EIT LLIF Trial

Primary DI
04260557837511
Brand
EIT LLIF Trial
Company
EIT Emerging Implant Technologies GmbH
Model
LET71655
Device description
Trial, H 16mm, 16°, 55/22
Published
2018-11-28
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260557837511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260557837511042605578375114260557837511

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
313088331
Device count
1
DM exempt
false
Premarket exempt
false
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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04260557770009EIT CIF cageCUI0040S2017-10-17
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04260557770023EIT CIF cageCUI0060S2017-10-20
04260557770030EIT CIF cageCUI0070S2017-10-20
04260557770047EIT CIF cageCUI0080S2017-10-20
04260557770054EIT CIF cageCUI0090S2017-10-20
04260557770061EIT CIF cageCUI0100S2017-10-20
04260557770078EIT CIF cageCUI0110S2017-10-20
04260557770085EIT CIF cageCUI0120S2017-10-20
04260557770092EIT CIF cageCUI0040L2017-10-20
04260557770108EIT CIF cageCUI0050L2017-10-20
04260557770115EIT CIF cageCUI0060L2017-10-20
04260557770122EIT CIF cageCUI0070L2017-10-20
04260557770139EIT CIF cageCUI0080L2017-10-20
04260557770146EIT CIF cageCUI0090L2017-10-20
04260557770153EIT CIF cageCUI0100L2017-10-20
04260557770160EIT CIF cageCUI0110L2017-10-20
04260557770177EIT CIF cageCUI0120L2017-10-20
04260557770184EIT CIF cageCUI004XL2017-10-20
04260557770191EIT CIF cageCUI005XL2017-10-20

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