FDA.reportPublic FDA data

Disposable valve for trocar D=3,5mm (x3)

Primary DI
E496C35SEAL30
Brand
Disposable valve for trocar D=3,5mm (x3)
Company
AB MEDICA
Model
C35-SEAL-3
Catalog number
C35-SEAL-3
Published
2020-03-03
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140101000ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARSAb Medica Sas2014-07-10GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E496C35SEAL31PrimaryHIBCC0
E496C35SEAL30Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal, single-useA small, sterile device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260445203
Device count
10
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E496C05ADPTPDH0LUER LOCK Adaptor for pneumodissectorC05-ADPT-PDHC05-ADPT-PDH2026-07-08
E496C05HPDH0Handle for pneumodissection HookC05-H-PDHC05-H-PDH2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useC05-ID-CH-20-STC05-ID-CH-20-ST2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useC05-ID-CH-33-STC05-ID-CH-33-ST2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useC35-ID-CH-20-STC35-ID-CH-20-ST2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useC35-ID-CH-33-STC35-ID-CH-33-ST2026-06-08
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmC35-BTU-20C35-BTU-202026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmC35-IB-DM-20C35-IB-DM-202026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmC35-IB-FS-20C35-IB-FS-202026-05-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07