FDA.reportPublic FDA data

VitreQ

Primary DI
88719214221641
Brand
VitreQ
Company
Vitreq B.V.
Model
CN25.D05
Device description
25G Blunt Needles with luer-lock connector
Published
2022-10-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
88719214221641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8871921422164188719214221641

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.866.906.8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
491393613
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719214220532VitreQFC23.R022022-10-13
08719214220549VitreQFC23.R032022-10-13
08719214220556VitreQFC23.R042022-10-13
08719214220563VitreQFC23.R052022-10-13
08719214220570VitreQFC25.R022022-10-13
08719214220587VitreQFC25.R032022-10-13
08719214220594VitreQFC25.R042022-10-13
08719214220600VitreQFC25.R052022-10-13
08719214220617VitreQFC27.R052022-10-13
08719214220655VitreQSC23.R012022-10-21
08719214220662VitreQSC23.R022022-10-21
08719214220679VitreQSC23.R032022-10-21
08719214220686VitreQSC25.R012022-10-21
08719214220693VitreQSC25.R022022-10-21
08719214220709VitreQSC25.R032022-10-21
08719214220723VitreQSC27.R032022-10-21
08719214221782VitreQFC00.R032022-10-13
08719214221799VitreQFC23.R062022-10-13
08719214221805VitreQFC25.R062022-10-13
08719214221997VitreQFC23.R072022-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08