FDA.reportPublic FDA data

Black Sterile packaged joystick 50 per box

Primary DI
B354I01610100
Brand
Black Sterile packaged joystick 50 per box
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
I0161010
Catalog number
I0161010
Device description
Black Sterile packaged joystick 50 per box
Published
2021-08-16
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

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B354I01610100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047063695
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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B3543000010ThoraClear Y Connector3000-012025-11-25
B354OS335MGTI0Grasper Traumatic Shaft insert 33 cm DisposableOS335MGTI2016-11-07
B354OS335MGTR0Grasper Traumatic with ratchet 33cm DisposableOS335MGT2016-11-07
B354OS445RTG0Rat Tooth Grasper, 44cm, DisposableOS445RTG2016-11-14
B354OS445RTGR0Rat Tooth Grasper w/Ratchet, 44cm, DisposableOS445RTGR2016-11-14
B354OSMCR4MMX5MR04mm Plug x 5M Monopolar Cable ReusableOSMCR4MMX5MR02016-11-15
B354HAF2LGS0Stainless Steel Cardiac 2 Finger Heart Retractor - SmallHAF2LGS2025-01-09
B354HAF2SHS0Stainless Steel Cardiac 2 Finger Heart Retractor - LargeHAF2SHS2025-01-09
B354HAF3LGS0Stainless Steel Cardiac 3 Finger Heart Retractor - SmallHAF3LGS2025-01-09
B354HAF3SHS0Stainless Steel Cardiac 3 Finger Heart Retractor - LargeHAF3SHS2025-01-09
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmOSLPCD510/122024-03-07
B354OS349440Needle Holder Straight 44cmOS349442024-01-24
B354CCBF14100Baton 10mm FoamCCBF14102024-02-21
B354CCBF1450Baton 5mm FoamCCBF1452024-02-21
B354CCLCS50Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm ShaftCCLCS52024-02-21
B354CCLCS80Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm ShaftCCLCS82024-02-21
B354CCS50Lens Cleaner Foam Sleeve for 5mm ShaftCCS52024-02-21
B354CCS51005mm x 10mm Foam SleevesCCS5102024-02-21
B354CCS80Lens Cleaner foam Sleeve for 8mm ShaftCCS82024-02-21
B354CCS81608mm x 16mm Foam SleevesCCS8162024-02-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
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08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09