Symblepharon Ring Conformer Medium, In Bulk

GUDID M87221414V93

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).

Oculo-Plastik Inc

Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic Symblepharon ring, synthetic
Primary Device IDM87221414V93
NIH Device Record Key9c4211ef-f1f5-44ec-a557-5957db948680
Commercial Distribution Discontinuation2022-03-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSymblepharon Ring Conformer Medium, In Bulk
Version Model Number21-414V
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com

Device Dimensions

Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter
Outer Diameter22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM87221414V93 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

[M87221414V93]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-25
Device Publish Date2016-10-16

Devices Manufactured by Oculo-Plastik Inc

10697660001903 - Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb .2022-03-25 The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various appl
10697660001927 - Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb.2022-03-25 The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various appl
10697660001965 - Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.2022-03-25 The Sutcliffe Boey is an instrument to treat cutaneous lesions (freckles, etc) during laser procedures. The holes limit the size
10697660001989 - Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)2022-03-25 The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat
10697660001996 - Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb.2022-03-25 The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat
10697660002023 - Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be
10697660002047 - Jaeger SS Lid Plate for the Laser (non glare), refurb.2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be
10697660003297 - Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends2022-03-25 Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.