FDA.report

Symblepharon Ring Conformer Small

Primary DI
M8722141204
Brand
Symblepharon Ring Conformer Small
Company
Oculo-Plastik Inc
Model
21-412
Device description
The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Published
2019-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HQNConformer, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HQNConformer, OphthalmicOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M8722141204PreviousHIBCC0
10697660002344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1069766000234410697660002344

GMDN Terms

TermDefinition
Symblepharon ring, syntheticAn implantable device formed as a circular band used to help prevent the eyelid from adhering to the eyeball. It is used occasionally in the case of, e.g., glaucoma, to keep raw surfaces separated. The device is made of synthetic material, e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, a polymer, or copolymer material.

Device Sizes

TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods

Method
Ethylene Oxide;Hydrogen Peroxide
Hydrogen Peroxide;Ethylene Oxide

Contacts

PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags

DUNS number
257382580
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10697660001903Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb .21-275R2019-11-21
10697660001927Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb.21-276R2019-11-21
10697660001965Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.21-287R2019-11-21
10697660001989Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)21-2892019-11-21
10697660001996Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb.21-289R2019-11-21
10697660002023Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.21-292R2019-11-21
10697660002047Jaeger SS Lid Plate for the Laser (non glare), refurb.21-295R2019-11-21
10697660003297Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends23-293Y2019-11-25
10697660003310Plastic Jaeger lid plates, t-yellow flater model with medium & large ends23-295Y2019-11-25
10697660003334Desmarres, Autoclavable plastic retractor t-yellow23-311Y2019-11-25
10697660003341Desmarres, Autoclavable plastic retractor t-yellow23-315Y2019-11-25
10697660003433Castroviejo Suturing Forceps (0.3 mm)25-1032019-11-21
10697660003440Castroviejo Suturing Forceps (0.3 mm), refurb.25-103R2019-11-21
10697660003457Castroviejo Suturing Forceps (0.5 mm)25-1052019-11-21
10697660003464Castroviejo Suturing Forceps (0.5 mm), refurb.25-105R2019-11-21
10697660003471Castroviejo Suturing Forceps (0.9 mm)25-1092019-11-21
10697660003488Castroviejo Suturing Forceps (0.9 mm), refurb.25-109R2019-11-21
10697660003495Castroviejo Suturing Forceps (1.2 mm)25-1122019-11-21
10697660003501Castroviejo Suturing Forceps (1.2 mm), refurb.25-112R2019-11-21
10697660003518Castroviejo Caliper (non glare)25-1402019-11-21

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