DEVICE: Surgical Direct (B382S34556000)
Device Identifier (DI) Information
Surgical Direct
S34556.00
In Commercial Distribution
S34556.00
Surgical Direct, Inc.
S34556.00
In Commercial Distribution
S34556.00
Surgical Direct, Inc.
Flieringa Fixation Ring, Stainless Steel with Polished Finish, Set Sold In 1mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
63431 | Intraocular retractor, reusable |
A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HND | Spatula, Ophthalmic |
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
bddce5f8-0dbd-46d9-9ec7-d426ca24a6c2
April 17, 2024
2
December 28, 2023
April 17, 2024
2
December 28, 2023
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(386) 738-1202
info@surgicaldirect.com
info@surgicaldirect.com