FDA.report

Safety Goggles, 532nm

Primary DI
08717872013930
Brand
Safety Goggles, 532nm
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
7005.F5
Catalog number
7005.F5
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQFLaser, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872013930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872013930087178720139308717872013930

GMDN Terms

TermDefinition
Laser filter, opticalAn eyepiece to an optical system, such as an endoscope, used during a laser procedure to protect the operator's eyes from laser energy transmitted through the optics. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
407522184
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08717872004280Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.1284.DIS1284.DIS2016-09-23
08717872008578Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.2267.NMD062267.NMD062016-09-30
08717872016771Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max2267.NMD042267.NMD042016-09-23
08717872017297Disposable Pneumatic Vitrectome, 25 Gauge/0.5 mm working with 37 PSI, max2500 c 2267.NMD052267.NMD052016-09-23
08717872021416Cryo Probe: Extended Retinal, 2.5mm1540.D1540.D2017-07-12
0871787203710325G Extendible subretinal injection cannula (41G)1270.EXT251270.EXT252025-09-26
0871787203711027G Extendible subretinal injection cannula (41G)1270.EXT271270.EXT272025-09-26
18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)3269.E06-002025-04-01
18717872035540TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)3269.EB05-002025-04-01
1871787203654727G Two Dimensional Cutter – 20k CPM9268.VIT27-002025-04-01
08717872034720EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.402-002025-03-31
18717872035397Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.43269.D04-002025-03-31
18717872035403Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 3269.D-002025-03-31
18717872035410TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga3269.B04-003269.B04-002025-03-31
1871787203542723 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor3269.SBS06-00 2025-03-31

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