FDA.reportPublic FDA data

Watson Extraction System

Primary DI
00197169170016
Brand
Watson Extraction System
Company
DEPUY (IRELAND)
Model
17001
Catalog number
17001A
Device description
Osteotome Handle
Published
2023-03-04
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
00197169170016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197169170016001971691700161971691700160197169170016

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome handleA hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
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
10603295518761SMARTSET5450-45-5005450455002026-09-10
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123946Micro OsteotomeSONTEC INSTRUMENTS, INC.HWM2026-10-27
00190776435516MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435523MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435592MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776437671MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437732MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437817MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776435127MillenniumAvalign Technologies, Inc.HWM2026-10-15
00190776435134MillenniumAvalign Technologies, Inc.HWM2026-10-15
00840277133915Innomed, Inc.INNOMED, INC.HWM2026-10-09
00190776434007MillenniumAvalign Technologies, Inc.HWM2026-10-08
00190776436261MillenniumAvalign Technologies, Inc.HWM2026-10-08
G141548807040Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141548807060Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141549966080Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141646640020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.HWM2026-10-06
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29
00190776432713MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432720MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432737MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21