FDA.reportPublic FDA data

AMO VITREPURE VITRECTOMY HANDPIECES AND

Primary DI
05050474500204
Brand
AMO VITREPURE VITRECTOMY HANDPIECES AND
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
OPO39
Catalog number
OPO39
Device description
VITRECTOMY CUTTER, TUBING SET
Published
2016-09-02
Public version status
Update
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
HQEINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15050474500201PackageGS16In Commercial Distribution
05050474500204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505047450020115050474500201
05050474500204050504745002045050474500204

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system handpieceA holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
103021940
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
00380650003294UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003300UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003317UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003614UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003621UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003638UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003669UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003676UNITYAlcon Laboratories, Inc.HQE2025-04-08
0871787203654027G Two Dimensional Cutter – 20k CPMD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-04-01
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
00380650003324UNITYAlcon Laboratories, Inc.HQE2024-11-19
00380650003348UNITYAlcon Laboratories, Inc.HQE2024-11-19
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-09-27
00380650001252UNITYAlcon Laboratories, Inc.HQE2024-07-02
08717872035109EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035116EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035123EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035307EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035314EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035321EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035338EVA NEXUS™ Combined 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21