FDA.reportPublic FDA data

ASI 2.0 Instruments

Primary DI
00887868347467
Brand
ASI 2.0 Instruments
Company
Biomet Uk Ltd
Model
110039141
Catalog number
110039141
Published
2020-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00887868347467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868347467008878683474678878683474670887868347467

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
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 DIBrandModelCatalogPublished
00889024683808Oxford® Partial Knee System5122111155122111152026-04-09
00889024683815Oxford® Partial Knee System5122111505122111502026-04-09
00889024683181Oxford® Partial Knee System1122111001122111002026-04-03
00889024683198Oxford® Partial Knee System1122112001122112002026-04-03
00889024683204Oxford® Partial Knee System1122113001122113002026-04-03
00889024683211Oxford® Partial Knee System1122114001122114002026-04-03
00889024683228Oxford® Partial Knee System1122115001122115002026-04-03
00889024683235Oxford® Partial Knee System1122116001122116002026-04-03
00889024683242Oxford® Partial Knee System1122117001122117002026-04-03
00889024683259Oxford® Partial Knee System1122211001122211002026-04-03
00889024683266Oxford® Partial Knee System1122212001122212002026-04-03
00889024683273Oxford® Partial Knee System1122213001122213002026-04-03
00889024683280Oxford® Partial Knee System1122214001122214002026-04-03
00889024683297Oxford® Partial Knee System1122215001122215002026-04-03
00889024683303Oxford® Partial Knee System1122216001122216002026-04-03
00889024683310Oxford® Partial Knee System1122217001122217002026-04-03
00889024683327Oxford® Partial Knee System1123111001123111002026-04-03
00889024683334Oxford® Partial Knee System1123112001123112002026-04-03
00889024683341Oxford® Partial Knee System1123113001123113002026-04-03
00889024683358Oxford® Partial Knee System1123114001123114002026-04-03

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Primary DI, Brand, Company table
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00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930022SURGIPROSSurgipros, LLCHWM2026-06-01
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00810212930046SURGIPROSSurgipros, LLCHWM2026-06-01
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00810212930077SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930084SURGIPROSSurgipros, LLCHWM2026-06-01
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00810212930107SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930114SURGIPROSSurgipros, LLCHWM2026-06-01
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