FDA.reportPublic FDA data

ENDOPATH

Primary DI
20705036011948
Brand
ENDOPATH
Company
ETHICON ENDO-SURGERY, LLC
Model
1SEAL
Catalog number
1SEAL
Device description
ONESEAL Reducer Caps
Published
2016-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705036011945PackageGS172Not in Commercial Distribution
40705036011942PackageGS1252Not in Commercial Distribution
20705036011948PrimaryGS10
10705036011941Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503601194530705036011945
4070503601194240705036011942
2070503601194820705036011948
1070503601194110705036011941

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal reducer, single-useA small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
044606982
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2026-05-27
10705036003113HARMONICTLB01TLB012016-07-15
20705036003271HARMONICTTBLUETTBLUE2016-07-15
20705036013904N/ACRT11CRT112016-07-15
20705036038396DUALTO Energy SystemETHEF2ETHEF22025-06-18
20705036038402DUALTO Energy SystemETHEF1ETHEF12025-06-18
20705036038419DUALTO Energy SystemETHERFETHERF2025-06-18
20705036038426DUALTO Energy SystemETHCRTETHCRT2025-06-18
20705036039287DUALTO Energy SystemETHOVKETHOVK2025-06-20
20705036038365DUALTO Energy SystemETHCMETHCM2025-06-18
20705036038372DUALTO Energy SystemETHUSCETHUSC2025-06-18
20705036038389DUALTO Energy SystemETHEMETHEM2025-06-18
10705036013143ProximateTCT55TCT552015-08-24
10705036013204PROXIMATETLC55TLC552015-08-24
10705036013006ProximatePPH03PPH032015-08-24
10705036013112ProximateTCD75TCD752015-08-24
10705036013150PROXIMATETCT75TCT752015-08-24
10705036013211PROXIMATETLC75TLC752015-08-24
10705036013389PROXIMATETVC55TVC552015-08-24
10705036002895ETHIBOND; DURAKNOTSW110SW1102016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029178EndoplusEndoplusHET2026-07-08
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29