Home GUDID 00810009465393 Osteotome, 8mm Tip, 6.5cm WL
Primary DI 00810009465393
Brand Osteotome, 8mm Tip, 6.5cm WL
Company MIZUHO AMERICA, INC.
Model 99-400-43
Device description Osteotome
Published 2022-12-02
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810009465393 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810009465393 00810009465393 810009465393 0810009465393
GMDN Terms# Term, Definition table Term Definition Plastic surgery osteotome A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting 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 either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 877624940 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 DI Brand Model Catalog Published 00810009460008 Micro Dilator Forceps, Bayonet, Angled Tip, 50mm WL 07-868-09MA 2025-12-09 00810009460213 Micro Dilator Forceps, Bayonet, Straight Tip, 35mm WL 07-868-07MA 2025-12-09 00810009466604 Micro Dilator Forceps, Bayonet, Straight Tip, 50mm WL 07-868-08MA 2025-12-09 00810009465331 Cottle Speculum, 110mm flared tip 99-200-09 2023-01-23 00810009465348 Papevero Speculum 70mm 99-200-17 2023-01-23 00810009465355 Trapezoidal Speculum 80mm down 99-200-18 2023-01-23 00810009465362 Multi-hole atraumatic suction 9fr 99-400-21 2022-12-05 00810009465416 Periosteal Elevator, Straight, 12mm Tip, 7.5cm WL 99-400-45 2022-12-02 00810009465492 Tenotomy Scissors, Straight Jaw, Ring Handle, Thin Blades, 11cm 99-600-33 2022-11-17 00810009460060 Ring Curette, Donut Style, 3mm, Offset, 15cm WL 10198MA 2023-08-15 00810009460152 LawtonElite Microscissors Bayonet, Reposable, Curved Right Blades, 10cm WL 10294MA 2023-08-15 00810009460169 LawtonElite Microscissors Bayonet, Reposable, Curved Left Blades, 10cm WL 10295MA 2023-08-15 00810009460541 Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL 02-082-45 2023-08-15 00810009460824 Yasargil Forceps, Bayonet, 11.5cm WL 07-110-10 2023-08-15 00810009461180 Ring Curette, Donut Style, 3mm, 125 Degrees Up, 15cm WL 10296MA 2023-08-15 00810009462132 Sizer Dissector, Straight 07-823-01 2023-08-15 00810009463054 Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL 07-829-11 2023-08-15 00810009463580 Sugita AVM Clip Case 07-932-00 2023-08-15 00810009463801 Biopsy Forceps, 1mm Spoon, 10cm WL 07-869-02 2023-08-15 00810009464129 Tapered Suction Tube, One Piece, 9Fr, 11cm WL 07-960-09L 2023-08-15
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