FDA.reportPublic FDA data

MSI

Primary DI
00810130206858
Brand
MSI
Company
Modern Surgical Instruments LLC
Model
68.9534
Device description
"Spurling Rongeur 12"" up 4x10mm"
Published
2025-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810130206858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810130206858008101302068588101302068580810130206858

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
118447158
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
00810130207565MSI71-20332026-09-28
00810130207541MSI49-03522026-09-24
00810130207558MSI49-03512026-09-24
B4193533010Maxtown Medical3-533-012026-08-27
00810130207459MSIFSP22462026-08-18
00810130207466MSIFSP2390A2026-08-18
00810130207473MSIFSP2390B2026-08-18
00810130207480MSIFSP22322026-08-18
00810130207497MSIFSP22332026-08-18
00810130207503MSIFSP22342026-08-18
00810130207510MSIFSP22442026-08-18
00810130207527MSIFSP22452026-08-18
00810130207534MSIFSP26972026-08-18
00810130207435MSI100012026-07-14
00810130207411MSI769-022026-05-12
00810130207404MSI83.72902026-04-01
00810130207367MSI99-00462026-03-12
00810130207374MSI99-00362026-03-12
00810130207381MSI99-00472026-03-12
00810130207398MSI99-00372026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
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