FDA.reportPublic FDA data

Trephine for Revision ø 5.5 mm Screw

Primary DI
08719425465661
Brand
Trephine for Revision ø 5.5 mm Screw
Company
Baat Medical Products B.V.
Model
42-440-55
Catalog number
N/A
Device description
Trephine for Revision ø 5.5 mm Screw
Published
2021-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
08719425465661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719425465661087194254656618719425465661

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
413205480
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720629959177SINEFIXSINEFIX Easy Grip600022025-07-03
08720629959184SINEFIXMedial Driver600032025-07-03
08720629959191SINEFIXLateral Driver600042025-07-03
08720629959207SINEFIXRepusher600052025-07-03
08720629959214SINEFIXSINEFIX Instrument Tray600062025-07-03
08720629950556ANSER Clavicle PinANSER Clavicle Pin SetANS-501S2022-12-14
08720629950563ANSER Clavicle PinANSER Manual Pin DriverANS-6022022-12-14
08720629950570ANSER Clavicle PinANSER TapANS-6032022-12-14
08720629950587ANSER Clavicle PinANSER Lat. Fix. Device InserterANS-6042022-12-14
08720629950594ANSER Clavicle PinANSER End Cap InserterANS-6052022-12-14
08720629950600ANSER Clavicle PinANSER TrayANS-7012022-12-14
08720629950617ANSER Clavicle PinANSER Instrument SetANS-7022022-12-14
08720629958057Kleiner KG2 systemKG2 Static Parallel 9x24x07x0° 02-911072023-08-30
08720629958064Kleiner KG2 systemKG2 Static Parallel 9x24x08x0°02-911082023-08-30
08720629958071Kleiner KG2 systemKG2 Static Parallel 9x24x09x0°02-911092023-08-30
08720629958088Kleiner KG2 systemKG2 Static Parallel 9x24x10x0°02-911102023-08-30
08720629958095Kleiner KG2 systemKG2 Static Parallel 9x24x11x0°02-911112023-08-30
08720629958101Kleiner KG2 systemKG2 Static Parallel 9x24x12x0°02-911122023-08-30
08720629958118Kleiner KG2 systemKG2 Static Parallel 9x24x13x0°02-911132023-08-30
08720629958125Kleiner KG2 systemKG2 Static Parallel 9x24x14x0°02-911142023-08-30

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