FDA.reportPublic FDA data

Clean Wave Rongeure with Kerrison Ring Handle, 7 x 12 mm, 330 mm working length

Primary DI
07640229291297
Brand
Clean Wave Rongeure with Kerrison Ring Handle, 7 x 12 mm, 330 mm working length
Company
Accuratus AG
Model
18.23.27
Device description
Clean Wave Rongeure with Kerrison Ring Handle, 7 x 12 mm, 330 mm working length, black coating CC
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640229291297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640229291297076402292912977640229291297

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
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
07640229290719Subtilis Bone Lever Hohmannn 8 mm 22 cm No. 2024.51.362020-07-30

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B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
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00190776405861MillenniumAvalign Technologies, Inc.HTX2026-07-26
00190776405885MillenniumAvalign Technologies, Inc.HTX2026-07-26
00840183532154BR Surgical, LLCBR Surgical, LLCHTX2026-07-22
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04058749058734NAFehling Instruments GmbH & Co. KGHTX2026-07-17
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