FDA.reportPublic FDA data

VitreQ

Primary DI
08719214220617
Brand
VitreQ
Company
Vitreq B.V.
Model
FC27.R05
Device description
27G Forceps, Eckardt Endgripping
Published
2022-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18719214220614Direct MarkingGS10
08719214220617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1871921422061418719214220614
08719214220617087192142206178719214220617

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manual, reusableA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
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
08719214222000VitreQFC25.R072022-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
05060411983007Capsulorhexis Forceps, Utrata Tips, 12mm Curved Shafts, Round HandlesDTR MEDICAL LIMITEDHNR2026-06-10
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D502002S0STORZ Utrata Capsulorhexis ForcepsDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5011895020COLIBRI FORCEP 0.4 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5019300STORZ CASTROVEIJO COLIBRI FORCEPS 0.12DAUD JEE MFG. COHNR2022-12-13
G006D5023500HOFFER-MCPHERSON FORCEPS DEL 11M LONG JAWSDAUD JEE MFG. COHNR2022-12-13
G006D5025000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D5025100CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D5025200CASTROVIEJO FORCEPS 0.5MM DAUD JEE MFG. COHNR2022-12-13
G006D5025300CASTROVIEJO FORCEPS 0.9MM DAUD JEE MFG. COHNR2022-12-13
G006D50253000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D502530010CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D502530020CASTROVIEJO FORCEPS 0.5MM DAUD JEE MFG. COHNR2022-12-13
G006D502530030CASTROVIEJO FORCEPS 0.9MM DAUD JEE MFG. COHNR2022-12-13
G006D5023000MCPHERSON FORCEPS 1X2 STR DAUD JEE MFG. COHNR2022-12-12
G006D5023100MCPHERSON FORCEPS 1X2 ANG DAUD JEE MFG. COHNR2022-12-12
G006D5023300KELMAN-MCPHERSON FORCEPS 8MM LONG JAWS, 0.3MMDAUD JEE MFG. COHNR2022-12-12
G006D5011895030COLIBRI FORCEP 0.12 W/TYING PLATFORM OBLIQUEDAUD JEE MFG. COHNR2022-12-10
G006D50131600French M patern Corneal forceps, delicate, 1x2 , 0.12DAUD JEE MFG. COHNR2022-12-10
G006D5015660HOFMANN-POLACK SUTURING FORCEPS 0.2MMDAUD JEE MFG. COHNR2022-12-10