Home GUDID 00190660129248 Ambler Surgical
Primary DI 00190660129248
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Bone file
Catalog number 69-124
Device description Bone file, 7'', double-ended, #33, 5.0mm and 6.0mm serrated ends, round handle
Published 2021-01-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660129248 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 00190660129248 00190660129248 190660129248 0190660129248
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, manual A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 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 00190660100360 Ambler Surgical Fiberoptic light cable 40-800 2021-01-04 00190660100377 Ambler Surgical Fiberoptic light cable 40-500 2021-01-04 00190660100384 Ambler Surgical Fiberoptic light cable 40-810 2021-01-04 00190660100391 Ambler Surgical Fiberoptic light cable 40-505 2021-01-04 00190660100407 Ambler Surgical Fiberoptic light cable 40-820 2021-01-04 00190660100414 Ambler Surgical Fiberoptic light cable 40-830 2021-01-04 00190660100421 Ambler Surgical Fiberoptic light cable 40-510 2021-01-04 00190660100438 Ambler Surgical Fiberoptic light cable 40-515 2021-01-04 00190660100445 Ambler Surgical Fiberoptic light cable 40-520 2021-01-04 00190660100452 Ambler Surgical Fiberoptic light cable 40-525 2021-01-04 00190660100469 Ambler Surgical Fiberoptic light cable 40-530 2021-01-04 00190660100476 Ambler Surgical Fiberoptic light cable 40-535 2021-01-04 00190660100483 Ambler Surgical Fiberoptic light cable 40-840 2021-01-04 00190660100490 Ambler Surgical Fiberoptic light cable 40-850 2021-01-04 00190660100506 Ambler Surgical Fiberoptic light cable 40-860 2021-01-04 00190660100513 Ambler Surgical Fiberoptic light cable 40-540 2021-01-04 00190660100520 Ambler Surgical Fiberoptic light cable 40-600 2021-01-04 00190660100537 Ambler Surgical Fiberoptic light cable 40-610 2021-01-04 00190660100544 Ambler Surgical Fiberoptic light cable 40-100 2021-01-04 00190660100551 Ambler Surgical Fiberoptic light cable 40-620 2021-01-04
Other Devices Sharing Product Codes# 
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