FDA.reportPublic FDA data

ExtravaStopper

Primary DI
20866497000336
Brand
ExtravaStopper
Company
Cannuflow, Inc.
Model
ESTOP
Catalog number
ESTOP
Device description
Portal Plug
Published
2024-01-16
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
FGYCannula, Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGYCannula, InjectionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20866497000336PackageGS110In Commercial Distribution
00866497000332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086649700033620866497000336
00866497000332008664970003328664970003320866497000332

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
138461384
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002896960TalarusTalarus 3-3TAL 3-32026-01-28
20860002896964TalarusTalarus 3-3TAL 3-32026-01-28
00860002896939SportPortSportPort 8.5 x 6SPORT 8-62024-01-16
00860002896946SportPortSportPort 6.5 x 6Sport 6-62024-01-16
00866497000301ClearVu 2.7 BluntCV27-BCV27-B2024-01-16
00866497000318ClearVu 2.7 SharpCV27-SCV27-S2024-01-16
00866497000325EntreVuEX-8-7TEVEX-8-7T2024-01-16
00866497000332ExtravaStopperESTOPESTOP2024-01-16
00866497000349TwoVuST-5TVST-52024-01-16
00866497000356TwoVuST-6TVST-62024-01-16
00866497000363TwoVuST-6LTVST-6L2024-01-16
00866497000370TwoVuST-6-130TVST-6-1302024-01-16
20860002896933SportPortSportPort 8.5 x 6SPORT 8-62024-01-16
20860002896940SportPortSportPort 6.5 x 6Sport 6-62024-01-16
20866497000305ClearVu 2.7 BluntCV27-BCV27-B2024-01-16
20866497000312ClearVu 2.7 SharpCV27-SCV27-S2024-01-16
20866497000329EntreVuEX-8-7TEVEX-8-7T2024-01-16
20866497000343TwoVuST-5TVST-52024-01-16
20866497000350TwoVuST-6TVST-62024-01-16
20866497000367TwoVuST-6LTVST-6L2024-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810192690701CerosRhino Medical Supply IncFGY2025-11-18
00810192690718CerosRhino Medical Supply IncFGY2025-11-18
00850041572994CerosRhino Medical Supply IncFGY2024-03-19
00866497000301ClearVu 2.7 BluntCannuflow, Inc.FGY2024-01-16
00866497000318ClearVu 2.7 SharpCannuflow, Inc.FGY2024-01-16
00866497000325EntreVuCannuflow, Inc.FGY2024-01-16
00866497000332ExtravaStopperCannuflow, Inc.FGY2024-01-16
00866497000349TwoVuCannuflow, Inc.FGY2024-01-16
00866497000356TwoVuCannuflow, Inc.FGY2024-01-16
00866497000363TwoVuCannuflow, Inc.FGY2024-01-16
00866497000370TwoVuCannuflow, Inc.FGY2024-01-16
20866497000305ClearVu 2.7 BluntCannuflow, Inc.FGY2024-01-16
20866497000312ClearVu 2.7 SharpCannuflow, Inc.FGY2024-01-16
20866497000329EntreVuCannuflow, Inc.FGY2024-01-16
20866497000343TwoVuCannuflow, Inc.FGY2024-01-16
20866497000350TwoVuCannuflow, Inc.FGY2024-01-16
20866497000367TwoVuCannuflow, Inc.FGY2024-01-16
20866497000374TwoVuCannuflow, Inc.FGY2024-01-16
00850023741875CER-SUB-1590RANFAC CORP.FGY2023-12-13
00614950029976ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00614950029983ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00190776308025MillenniumAvalign Technologies, Inc.FGY2023-06-23
06936841208098IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812197IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812203IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812210IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812227IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812234IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816843IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816850IV cannulaTianck Medical Co., Ltd.FGY2023-02-06