FDA.report

Sklar

Primary DI
10649111429347
Brand
Sklar
Company
SKLAR CORPORATION
Model
43-4631
Device description
CLOWARD RONG 6X10 STR CT DT 4.75
Published
2019-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTXRONGEUR

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10649111429347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1064911142934710649111429347

GMDN Terms

TermDefinition
Neurosurgical rongeurA hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
006966006
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150066872Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-03-20
00192896122864Velociraptor Junior RongeurSONTEC INSTRUMENTS, INC.HTX2026-03-19
00198506089626ELMED INCORPORATEDELMED INCORPORATEDHTX2026-03-17
04052536018314tezoUlrich GmbH & Co. KGHTX2026-03-16
04052536018321tezoUlrich GmbH & Co. KGHTX2026-03-16
04052536017768tezoUlrich GmbH & Co. KGHTX2026-03-12
04052536017775tezoUlrich GmbH & Co. KGHTX2026-03-12
M9308302T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308303T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308304T00Life InstrumentsLife Instrument CorporationHTX2026-03-06
M9308308H0Life InstrumentsLife Instrument CorporationHTX2026-03-06
M930831103330Life InstrumentsLife Instrument CorporationHTX2026-03-06
04058749055276NAFehling Instruments GmbH & Co. KGHTX2026-03-05
04058749097238NAFehling Instruments GmbH & Co. KGHTX2026-03-05
B382SD9228132130Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD922813214Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD62240190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62241190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD91931609Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62003250Surgical DirectSurgical Direct, Inc.HTX2026-02-09
B382SD923811300Surgical DirectSurgical Direct, Inc.HTX2026-02-09
00199150067114Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067121Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067138Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067145Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067152Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067169Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067176Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067183Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07
00199150067190Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTX2026-02-07