FDA.report

Symmetry Surgical®

Primary DI
00887482103203
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
58-5230J-BD
Catalog number
58-5230J-BD
Device description
RapidClean® Rongeur, Micro, Thin Footplate w/Ejector, 40° Up, Creamic Coated, Convertible, 5 mm, 9 in
Published
2022-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482103203PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Angle40degree
Length9Inch
Width5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

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