FDA.reportPublic FDA data

Subtilis Osteotome Lambotte curved 20 mm 25 cm

Primary DI
07640229291204
Brand
Subtilis Osteotome Lambotte curved 20 mm 25 cm
Company
Accuratus AG
Model
35.57.71
Device description
Subtilis Osteotome Lambotte curved 20 mm 25 cm
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640229291204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640229291204076402292912047640229291204

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483290367
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640229291280Clean Wave Rongeure with Kerrison Ring Handle, 4 x 10 mm, 330 mm working length18.23.242026-02-04
07640229291297Clean Wave Rongeure with Kerrison Ring Handle, 7 x 12 mm, 330 mm working length18.23.272026-02-04
07640229292348Tissue Forceps Adson fine, 1x2 teeth, 1.2 mm, 15 cm 07.20.152025-08-12
07640229293253Subtilis juvenile Bone Lever negative 24 x 45 mm, 27 cm, No. 18J24.51.1442025-08-12
07640229290184Subtilis Pelvis Lever with Propylux®plastic handle 26 mm 38 cm No. 5724.51.902020-07-30
07640229290368Subtilis lever for the trochant bone 40° with two long peaks 30mm /33 cm No. 4524.51.722020-07-30
07640229290399Subtilis bone lever with long soft-tissue protection 40° angled 18x75 mm 28 cm N24.51.39L2020-07-30
07640229290443Subtilis Bone Lever Ganz 24 mm 27 cm No. 2624.51.422020-07-30
07640229290467Subtilis Bone Lever double angled 20 mm / 31 cm No. 3724.51.572020-07-30
07640229290511Subtilis Hohmann lever 41 x 65 mm / 34 cm No. 55L24.51.63L2020-07-30
07640229290528Subtilis Bone Lever Hohmann 12 mm 22 cm No. 2124.51.372020-07-30
07640229290535Subtilis hip lever two tips double angled longer soft-tissue support large radiu24.51.76L2020-07-30
07640229290580Subtilis Bone Lever 24 mm blunt double-angled 25 cm No. 2524.51.412020-07-30
07640229290610Subtilis Bone Lever double angled 15 x 44mm / 28cm, No 2924.51.482020-07-30
07640229290627Subtilis Hip Lever 24 mm blunt, 27 cm No. 2424.51.402020-07-30
07640229290634Subtilis Bone Lever Hohmannn 18x37 mm 24 cm No. 2224.51.382020-07-30
07640229290641Subtilis Bone Lever Amin large 32 / 30 cm No. 3124.51.512020-07-30
07640229290658Subtilis Bone Lever Amin narrow 22 / 29 cm No. 3024.51.502020-07-30
07640229290689Subtilis Bone Lever deep 22 / 29 cm No. 3224.51.522020-07-30
07640229290696 Subtilis Pubis Lever Ganz, with long beak-shaped 22/260 mm n°2724.51.452020-07-30

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