FDA.reportPublic FDA data

VitreQ

Primary DI
88719214223454
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
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

Contacts#

Phone, Email table
PhoneEmail
1.866.906.8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
491393613
Device count
1
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
08719214223458VitreQVitreq B.V.HPS2021-02-01
10850510007597MIRA Cryosurgical Probe, Lashkari TrichiasisMIRA, INC.HPS2016-09-24