FDA.reportPublic FDA data

Synergetics

Primary DI
20841305108398
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
65033E
Catalog number
65033E
Device description
23ga Core Essentials™ Vitrectomy Pack, 3ft Cutter
Published
2017-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
20841305108398PackageGS16In Commercial Distribution
10841305101910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510839820841305108398
1084130510191010841305101910

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021056726
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10841305101118Synergetics18067180672020-09-18
10841305101064Synergetics18060180602020-05-31
10841305101071Synergetics18061180612020-05-31
10841305101088Synergetics18063180632020-05-31
10841305101095Synergetics18064180642020-05-31
10841305101125Synergetics18069180692020-05-31
10841305101132Synergetics18069W18069W2020-05-31
10841305101156Synergetics31.0231.022020-09-18
10841305101163Synergetics41.0041.002020-09-18
10841305101231Synergetics16579165792020-09-18
10841305101255Synergetics12.06.2512.06.252020-09-18
10841305101309Synergetics17570175702017-12-30
10841305101316Synergetics17580175802020-09-18
10841305101323Synergetics17680176802020-09-18
10841305101330Synergetics19020190202020-09-18
10841305101415Synergetics30.08.2330.08.232020-09-18
10841305101422Synergetics30.08.2530.08.252020-09-18
10841305101439Synergetics30.08.2730.08.272020-09-18
10841305101446Synergetics30.1030.102020-09-18
10841305101453Synergetics30.10.2330.10.232020-09-18

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