FDA.reportPublic FDA data

Life Instruments

Primary DI
M930732804020
Brand
Life Instruments
Company
Life Instrument Corporation
Model
732-8040-2
Device description
"8"" Toothed Pituitary Rongeur 4mm Down"
Published
2021-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M930732804020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
M93071015023S10Life Instruments710-1502-3S-12026-09-21
M93071015024S10Life Instruments710-1502-4S-12026-09-21
M93071715021C900Life Instruments717-1502-1C-902026-09-21
M93071715022C900Life Instruments717-1502-2C-902026-09-21
M93071715031C900Life Instruments717-1503-1C-902026-09-21
M93071715032C900Life Instruments717-1503-2C-902026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
00190776427962MillenniumAvalign Technologies, Inc.HTX2026-08-27
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur ShaftSONTEC INSTRUMENTS, INC.HTX2026-08-25
B382SD9227656000Surgical DirectSurgical Direct, Inc.HTX2026-08-21
00190776426682MillenniumAvalign Technologies, Inc.HTX2026-08-19
00190776426699MillenniumAvalign Technologies, Inc.HTX2026-08-19
B382SD922812030Surgical DirectSurgical Direct, Inc.HTX2026-08-07
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4829130Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4882030Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD488603SLH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
00190776422455MillenniumAvalign Technologies, Inc.HTX2026-07-31
B382SD1450500050Surgical DirectSurgical Direct, Inc.HTX2026-07-31
B382SD914848050Surgical DirectSurgical Direct, Inc.HTX2026-07-28