FDA.reportPublic FDA data

SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN

Primary DI
M648C0100110
Brand
SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN
Company
OBP CORPORATION
Model
C010011
Device description
C010011 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN (Customer REF 26153EAU/10)
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)
HIHHysteroscope (And Accessories)
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M648C0100111PackageHIBCC10In Commercial Distribution
M648C0100110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel sealA sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.

Regulatory Flags#

DUNS number
011560431
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M648C1002500ONETRAC LXC100250C1002502025-07-01
M648C1002501ONETRAC LXC100250C1002502025-07-01
M648C0601000ANOSPEC C060100 C060100 2016-09-21
M648C0601100ANOSPEC C060110 C060110 2016-09-21
M648C0601200ANOSPEC C060120 C060120 2016-09-21
M648C0601002ANOSPEC C060100 C060100 2016-09-21
M648C0601102ANOSPEC C060110 C060110 2016-09-21
M648C0601202ANOSPEC C060120 C060120 2016-09-21
M648C1102100ONETRAC LXSC110210C1102102022-04-15
M648C1102200ONETRAC LXSC110220C1102202022-04-15
M648C1102101ONETRAC LXSC110210C1102102022-04-15
M648C1102201ONETRAC LXSC110220C1102202022-04-15
M648C1002800ONETRAC LXC1002802021-06-02
M648C1002900ONETRAC LXC1002902021-06-02
M648C1002801ONETRAC LXC1002802021-06-02
M648C1002901ONETRAC LXC1002902021-06-02
M648C1102000ONETRAC LXSC110200C1102002021-04-12
M648C1102001ONETRAC LXSC110200C1102002021-04-12
M648C1002020ELBOW CONNECTORC1002022020-10-22
M648C1002021ELBOW CONNECTORC1002022020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06973141950845EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2026-07-16
00817401029178EndoplusEndoplusHET2026-07-08
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
06973786290337Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290344Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290368Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290375Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290399Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
06973786290405Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)ODC2024-10-25
08057502310108Endorail SetENDOSTART SRLODC2024-10-16
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
04953170451980Luer-Split MAJ-2092OLYMPUS MEDICAL SYSTEMS CORP.ODC2022-08-05