FDA.report

Ritch Panoramic Surgical Gonioprism Lens

Primary DI
00630238102001
Brand
Ritch Panoramic Surgical Gonioprism Lens
Company
OCULAR INSTRUMENTS, INC.
Model
ORPSG
Published
2019-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HKSPrism, Gonioscopic

Product Code Classifications

CodeDeviceSpecialtyClass
HKSPrism, GonioscopicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630238102049Direct MarkingGS10
00630238102001PrimaryGS10

GMDN Terms

TermDefinition
GonioscopeA device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
046212387
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00630238008075Koeppe Large Diagnostic Lens 19mm O.D.OKL2019-06-12
00630238008099Koeppe Medium Diagnostic Lens 18mm O.D.OKM2019-06-12
00630238008105Koeppe Small Diagnostic Lens 17mm O.D.OKS2019-06-12
00630238008549Koeppe Extra Small Diagnostic Lens 16mm O.D.OKES-162019-06-12
00630238009973Landers Lens ForcepsOLV-FCP2019-06-12
00630238041072Koeppe Extra Small Diagnostic Lens 14mm O.D.OKES-142019-06-12
00630238056656Handle For Vitrectomy LensesOLIV-H2019-06-12
00630238077255Landers Short Two Strut Vitrectomy Lens RingOLVR-S2S2019-06-12
00630238077330Landers Short Notched Vitrectomy Lens RingOLVR-S3N2019-06-12
00630238108201Glaukos® iprism® (Left-Handed)OTB/LH-22019-06-12
00630238108256Glaukos® iprism® (Right-Handed)OTB/RH-22019-06-12
00630238113465Reichel OCT SteadyEyeOROCTS2019-06-12
00630238118903Upright 1.3x Surgical Gonio LensOUSG-1.3X2019-06-12

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