FDA.reportPublic FDA data

EntreVu

Primary DI
00866497000325
Brand
EntreVu
Company
Cannuflow, Inc.
Model
EX-8-7T
Catalog number
EVEX-8-7T
Device description
Instrument Cannula
Published
2024-01-16
Public version status
New
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
FGYCannula, Injection

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20866497000329PackageGS15In Commercial Distribution
00866497000325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086649700032920866497000329
00866497000325008664970003258664970003250866497000325

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter8Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
138461384
Device count
1
Premarket exempt
true
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
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
20866497000336ExtravaStopperESTOPESTOP2024-01-16
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
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
20866497000336ExtravaStopperCannuflow, 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