FDA.reportPublic FDA data

Subtilis Bone Lever Hohmann 12 mm 22 cm No. 21

Primary DI
07640229290528
Brand
Subtilis Bone Lever Hohmann 12 mm 22 cm No. 21
Company
Accuratus AG
Model
24.51.37
Device description
Subtilis Bone Lever Hohmann 12 mm 22 cm No. 21
Published
2020-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640229290528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640229290528076402292905287640229290528

GMDN Terms#

Term, Definition table
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.

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
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
07640229290719Subtilis Bone Lever Hohmannn 8 mm 22 cm No. 2024.51.362020-07-30

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