FDA.reportPublic FDA data

Side Cutter

Primary DI
04250337120162
Brand
Side Cutter
Company
Joimax GmbH
Model
JSBSC1555
Catalog number
JSBSC1555
Device description
Side Cutter, Barrel Tip, with side protection
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337120216PrimaryGS10
04250337120162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120216042503371202164250337120216
04250337120162042503371201624250337120162

GMDN Terms#

Term, Definition table
TermDefinition
Spinal shaver system bladeA cutting device designed for use in a powered spinal decompression shaver system handpiece (not included) for bone and soft-tissue resection during spinal surgery. It is locked into the handpiece and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
5
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337100942Sealing CapSCLL15202026-10-29
04250337112860Closing Cap for joimax® endoscopesTCC2008052026-10-29
04250337118831joimax® Vitegra® Foot SwitchJVFS00012026-10-29
04250337120308Biportal Laminoscope, okularBS4015175O-4K2026-10-29
04250337120605Biportal Laminoscope, okularBS4000175O-4K2026-10-29
04250337120643Biportal Laminoscope, okularBS4030175O-4K2026-10-29
04250337120971Camsource® Duo Control UnitCSD4K012026-10-29
04250337121053Endoscope Adapter for iLESSYS® Delta LaminoscopeRFEAID10A2026-10-29
04250337121060Coupling nut for endoscope adapterRFEACS2026-10-29
04250337121077Adapter holderRFADH2026-10-29
04250337121084HofHolderEHFS63422026-10-29
04250337121107HofHolderEHFS6342-4K2026-10-29
04250337121114HofHolderEHFS7342-4K2026-10-29
04250337121121HofHolderEHFS73422026-10-29
04250337121138HofHolderEHLS1006-4K2026-10-29
04250337121145HofHolderEHLS10062026-10-29
04250337121152HofHolderEHLS7342-4K2026-10-29
04250337121169HofHolderEHLS73422026-10-29
04250337121183Locking screw for endoscope adapterRFEALS2026-10-29
04250337121626joimax® Intracs® EM Patient Tracker 3DJINTPT3D2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"Joimax GmbHHWE2026-10-29
04250337122388Deflector Bone Resector, Bullet-Tip, disposableJoimax GmbHHWE2026-10-29
04250337122395Deflector Diamond Abrasor, disposableJoimax GmbHHWE2026-10-29
04250337122401Deflector Bone Resector, Ball-Tip, disposableJoimax GmbHHWE2026-10-29
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-23
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20