FDA.reportPublic FDA data

Endo Carry-on Procedure Kit

Primary DI
00677964154348
Brand
Endo Carry-on Procedure Kit
Company
MEDIVATORS INC.
Model
4011715
Catalog number
4011715
Device description
Endo Carry-on Procedure Kit contains Intercept Bedside Kit, STERIS Olympus Bronchoscopy 2-Piece Kit, Absorbant Pad, Gauze, and Gown.
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50677964154343PackageGS116In Commercial Distribution
00677964154348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5067796415434350677964154343
00677964154348006779641543486779641543480677964154348

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00677964154133Endo Carry-on Procedure Kit401156440115642026-10-28
00677964154140Endo Carry-on Procedure Kit401156540115652026-10-28
00677964154157Endo Carry-on Procedure Kit401156740115672026-10-28
00677964154164Endo Carry-on Procedure Kit401157740115772026-10-28
00677964154171Endo Carry-on Procedure Kit401157840115782026-10-28
00677964154188Endo Carry-on Procedure Kit401169040116902026-10-28
00677964154195Endo Carry-on Procedure Kit401168040116802026-10-28
00677964154201Endo Carry-on Procedure Kit401168240116822026-10-28
00677964154218Endo Carry-on Procedure Kit401168340116832026-10-28
00677964154225Endo Carry-on Procedure Kit401168440116842026-10-28
00677964154232Endo Carry-on Procedure Kit401168540116852026-10-28
00677964154249Endo Carry-on Procedure Kit401168640116862026-10-28
00677964154256Endo Carry-on Procedure Kit401158140115812026-10-28
00677964154263Endo Carry-on Procedure Kit401168140116812026-10-28
00677964154270Endo Carry-on Procedure Kit401169640116962026-10-28
00677964154287Endo Carry-on Procedure Kit401169740116972026-10-28
00677964154294Endo Carry-on Procedure Kit401170240117022026-10-28
00677964154300Endo Carry-on Procedure Kit401170140117012026-10-28
00677964154317Endo Carry-on Procedure Kit401171240117122026-10-28
00677964154324Endo Carry-on Procedure Kit401171340117132026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964154133Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154140Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154157Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154164Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154171Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154188Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154195Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154201Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154218Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154225Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154232Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154249Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154256Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154263Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154270Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154287Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154294Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154300Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154317Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154324Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154331Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154355Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154362Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154379Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154386Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154393Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154409Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154416Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154423Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154430Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28