FDA.reportPublic FDA data

MicroLap Irrigation Tube Dolphin L=200MM

Primary DI
E496LILCD200
Brand
MicroLap Irrigation Tube Dolphin L=200MM
Company
AB MEDICA
Model
LIL-CD-20
Published
2018-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151822000ab medica irrigation/suction gravity systemAb Medica Sas2015-09-04GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E496LILCD200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic irrigation/aspiration cannulaA rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
260445203
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E496C35IBDM330C35- Bipolar Maryland Insert L33cm D 3,5mmC35-IB-DM-33C35-IB-DM-332026-05-21
E496C35SEAL11Disposable valve for trocar D=3,5mmC35-SEAL-1C35-SEAL-12020-03-03
E496C35SEAL31Disposable valve for trocar D=3,5mm (x3)C35-SEAL-3C35-SEAL-32020-03-03
E296LILSEAL11Disposable valves for trocar Ø 3 mmLIL-SEAL-12018-07-13
E296LILSEAL31Disposable valves for trocar Ø 3 mmLIL-SEAL-32018-07-19
E496LILIP2SC20ST0Low Impact™ Curved Scissors, Jaw Insert (sterile) L=20cm LIL-IP-2SC-20STLIL-IP-2SC-20ST2021-06-11
E496C35HH330C35-Hand Activated HOOK L=330mmC35-HH-33C35-HH-332021-07-23
E496COEC3501200REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=120MMCOEC350120COEC3501202021-07-23
E496COEC350600REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=60MMCOEC35060COEC350602021-07-23
E496COEC350750REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=75MMCOEC35075COEC350752021-07-23
E496COEC351000REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=100MMCOEC35100COEC351002021-07-23
E496C35IP2AL330C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3,5mmC35-IP-2AL-33C35-IP-2AL-332021-04-01
E496C35IP2BI330C35-Biopsy 2 mobile jaws insert L 33cm D 3,5mmC35-IP-2BI-33C35-IP-2BI-332021-04-01
E496C35IP2CL330C35-Clutch 2 mobile jaws insert L 33cm D 3,5mmC35-IP-2CL-33C35-IP-2CL-332021-04-01
E496C35IP2DC330"C35-""C"" Shape Dissector, Jaw Insert L=33mm D=3,5mm"C35-IP-2DC-33C35-IP-2DC-332021-04-01
E496C35IPS20330C35-20mm Tapered insert L 33cm D 3,5mmC35-IP-S20-33C35-IP-S20-332021-04-01
E496C35IPSM330C35- SEMM insert 1movable jaws L 33cm D 3,5mmC35-IP-SM-33C35-IP-SM-332021-04-01
E496C05NS350MicroLap Needle Driver - Straight L=35cm D=5mmC05-NS-352019-05-07
E496C05NS500MicroLap Needle Driver - Straight L=50cm D=5mmC05-NS-502019-05-07
E496LILNS200MicroLap Needle Driver - Straight 200mmLIL-NS-202018-07-13

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