FDA.report

Avenue T

Primary DI
03662663002721
Brand
Avenue T
Company
LDR Spine Usa, Inc.
Model
AT9014R
Catalog number
AT9014R
Published
2019-01-03
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663002721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663002721036626630027213662663002721

GMDN Terms

TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Device Sizes

TypeValueUnit
Angle5degree
Height13Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags

DUNS number
615789729
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
false
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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03662663059176Mobi-C Plug & Fit USMB9174R2024-01-15
03662663059183Mobi-C Plug & Fit USMB9176R2024-01-15
03662663059145Mobi-C Plug & Fit USMB9100R2024-01-12
03662663059152Mobi-C Plug & Fit USMB9101R2024-01-12
03662663000215Mobi-CMB900RMB900R2018-12-12
03662663000222Mobi-CMB903RMB903R2018-12-13
03662663000239Mobi-CMB904RMB904R2018-12-12
03662663000246Mobi-CMB906RMB906R2018-12-12
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663000376Mobi-CMB943RMB943R2018-12-13
03662663000383Mobi-CMB944RMB944R2018-12-13
03662663000390Mobi-CMB945RMB945R2018-12-13
03662663000406Mobi-CMB946RMB946R2018-12-13
03662663000413Mobi-CMB947RMB947R2018-12-13
03662663000420Mobi-CMB948RMB948R2018-12-13
03662663000437Mobi-CMB949RMB949R2018-12-13
03662663000819Mobi-C® Plug & Fit USMB9008R2014-09-24
03662663000826Mobi-C® Plug & Fit USMB9009R2014-09-24
03662663000833Mobi-C® Plug & Fit USMB9010R2014-09-24

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