DEVICE: Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid (08175700105545)
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Device Identifier (DI) Information
Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sid
AS1-352S
In Commercial Distribution
AS1-352S
AURORA SURGICAL, LLC
AS1-352S
In Commercial Distribution
AS1-352S
AURORA SURGICAL, LLC
Gimbel Stabilization Ring, Offset 13mm with 9mm opening, Blunt Teeth On Both Sides Of Swivel
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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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? |
|---|---|---|---|---|
| 62917 | Eyeball fixation instrument, reusable |
A hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HNH | Ring, Ophthalmic (Flieringa) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
3f903a5c-38ef-4804-9c30-41fe9ace9ffc
November 22, 2022
1
November 14, 2022
November 22, 2022
1
November 14, 2022
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined