VitreQ

Primary DI
08719214223458
Brand
VitreQ
Company
Vitreq B.V.
Model
CT00.D01
Device description
CryoTreQ
Published
2021-02-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPSUnit, Cryophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPSUnit, CryophthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202038000CryoTreQVitreQ BV2020-12-30HPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719214223458PackageGS13In Commercial Distribution
88719214223454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719214223458087192142234588719214223458
8871921422345488719214223454

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cryosurgical system, mechanicalAn assembly of mechanical devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes a mechanical regulator to control the flow of cryogen contained in an attached cylinder, and dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue. The device is typically used to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumours.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.866.906.8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
491393613
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
88719214223454VitreQVitreq B.V.HPS2021-02-01
10850510007597MIRA Cryosurgical Probe, Lashkari TrichiasisMIRA, INC.HPS2016-09-24