DEVICE: Ambler Surgical (10190660199538)
Device Identifier (DI) Information
Ambler Surgical
Hersch LASIK irrigating cannula
In Commercial Distribution
205252
AMBLER SURGICAL CORP.
Hersch LASIK irrigating cannula
In Commercial Distribution
205252
AMBLER SURGICAL CORP.
Hersch LASIK irrigating cannula, 23 gauge x 7/8'', spatulated tip, packaged individually, sterile, disposable, box of 10
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
46705 | Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use |
A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HMX | Cannula, ophthalmic |
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
033f7dc1-7bd7-4d1f-8a11-5b485d2c8f9b
January 12, 2021
1
January 04, 2021
January 12, 2021
1
January 04, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00190660199531 | 10 | 10190660199538 | In Commercial Distribution | BX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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(888)407-0006
0
sales@amblersurgical.com
sales@amblersurgical.com