FDA.report

Lachrymal Cannula (Curved) 26g x 1,25" (0.45 x 32mm)

Primary DI
18717872012503
Brand
Lachrymal Cannula (Curved) 26g x 1,25" (0.45 x 32mm)
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
52.1276
Catalog number
52.1276
Published
2021-01-29
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

Related Records

Product Codes

CodeName
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872012506PrimaryGS10
18717872012503Unit of UseGS10

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
407522184
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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08717872001401Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max.1267.NMD051267.NMD052016-09-30
08717872001425Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max.1267.NMD251267.NMD252016-09-30
08717872003085Infusion cannula forceps127612762020-11-16
08717872003115Scleral plug forceps127712772020-11-16
08717872003375Charles Flute instrument.128112812020-11-16
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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