DEVICE: Symblepharon Ring Conformer Large (10697660002382)

Device Identifier (DI) Information

Symblepharon Ring Conformer Large
21-416
In Commercial Distribution

Oculo-Plastik Inc
10697660002382
GS1

1
257382580 *Terms of Use
M8722141608
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).
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16073 Symblepharon ring, synthetic
An 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HQN Conformer, Ophthalmic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 24 Millimeter
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Device Record Status

cf8e0a02-fbaf-406b-9c84-6c9c44dc9765
October 31, 2019
1
October 23, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
514-381-3292
sales@oculoplastik.com
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