FDA.reportPublic FDA data

Life Instruments

Primary DI
M9307531058110
Brand
Life Instruments
Company
Life Instrument Corporation
Model
753-1058-1-1
Device description
"Soft Tissue Screw Retractor w/5"" handle"
Published
2021-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9307531058110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
948025002
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M93072110120F0Life Instruments 721-1012-0F2026-05-18
M9306440000T0Life Instruments644-0000-T2026-05-11
M930702110900Life Instruments702-1109-02026-05-11
M930702120820Life Instruments 702-1208-22026-05-11
M930702122800Life Instruments702-1228-02026-05-11
M930702140800Life Instruments702-1408-02026-05-11
M930702200500Life Instruments 702-2005-02026-05-11
M930702200520Life Instruments702-2005-22026-05-11
M930702232000Life Instruments 702-2320-02026-05-11
M930702831500Life Instruments702-8315-02026-05-11
M930706002000Life Instruments702-0020-02026-05-11
M9307251015020Life Instruments725-1015-0-22026-05-11
M9307850001T0Life Instruments 785-0001-T2026-05-11
M9307860000T0Life Instruments786-0000-T2026-05-11
M930703001000Life Instruments703-0010-02022-02-04
M930703100500Life Instruments703-1005-02022-02-04
M9307411230030Life Instruments741-1230-0-32026-03-23
M93071015043S20Life Instruments 710-1504-3S-22026-03-23
M93071015044S20Life Instruments710-1504-4S-22026-03-23
M93074301120SB0Life Instruments743-0112-0SB2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10