FDA.report

Iris Retractor.

Primary DI
18717872009657
Brand
Iris Retractor.
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
4020
Catalog number
4020
Published
2021-01-07
Public version status
New
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
HOCClip, Iris Retractor

Product Code Classifications

CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872009650PrimaryGS10
18717872009657Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872009650087178720096508717872009650
1871787200965718717872009657

GMDN Terms

TermDefinition
Intraocular retractor, single-useA sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
407522184
Device count
5
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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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
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18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)3269.E06-002025-04-01
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