DEVICE: Wexler Surgical, Inc. (M944BL0010410)
Device Identifier (DI) Information
Wexler Surgical, Inc.
BL0010.4-1
In Commercial Distribution
WEXLER SURGICAL, INC.
BL0010.4-1
In Commercial Distribution
WEXLER SURGICAL, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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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? |
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16413 | Corneal bur, rust ring removal, reusable |
A small shaft made of a hard metal (e.g., steel) with fluting or cutting planes designed for gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object. It is attached to the tip of a special slow-rotation powered ophthalmic handpiece. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OHW | Burr, Corneal, Battery Powered, Rust Ring Removal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bb544a98-ce53-4858-9f43-5bed2293d0bf
November 23, 2021
3
March 02, 2018
November 23, 2021
3
March 02, 2018
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 |
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GS1 | 00840240911366 |
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
[?]
No Customer Contact currently defined