FDA.reportPublic FDA data

L-Varlock

Primary DI
00850011324059
Brand
L-Varlock
Company
SPINESOURCE INC
Model
059
Catalog number
DS-110
Device description
Instrument, Disc Shaver, 10mm
Published
2019-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011324059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011324059008500113240598500113240590850011324059

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store away from light and sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
150955560
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011324158L-Varlock158VAL-CA-13-092021-06-03
00850011324165L-Varlock165VAL-CA-13-112021-06-03
00850011324134L-Varlock134VAL-CA-13-132020-11-24
00850011324141L-Varlock141HD00642020-12-02
00850011324028L-Varlock028DS-1072019-08-22
00850011324035L-Varlock035DS-1082019-08-22
00850011324042L-Varlock042DS-1092019-08-22
00850011324066L-Varlock066DS-1112019-08-22
00850011324073L-Varlock073DS-1122019-08-22
00850011324080L-Varlock080DS-1132019-08-22
00850011324127L-Varlock127SP-0022020-01-22
00850011324110L-Varlock110VAL-CA-10-092019-11-12
00850011324097L-Varlock097SD-41002019-10-11
00850011324103L-Varlock103HA-0022019-10-11
00850011324004L-Varlock004VAL-CA-13-082019-08-15
00850011324011L-Varlock011SP-0012019-08-15

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