FDA.reportPublic FDA data

Biportal Laminoscope, okular

Primary DI
04250337120605
Brand
Biportal Laminoscope, okular
Company
Joimax GmbH
Model
BS4000175O-4K
Published
2026-10-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051827000JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPEJoimax GmbH2005-08-12HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337120605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120605042503371206054250337120605

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49721255140info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 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
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
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"JSBDS32452026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337120308Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120643Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLHRX2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03