| Primary Device ID | 00840516142500 | 
| NIH Device Record Key | d5a8ccb9-22e1-44d3-93f8-594605a2e2e4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Anodyne Surgical | 
| Version Model Number | CQ1002 | 
| Company DUNS | 063763833 | 
| Company Name | Psi/Eye-Ko, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | |
| Phone | 1(800)428-5628 | 
| info@anodynesurgical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840516142500 [Primary] | 
| HNR | Forceps, Ophthalmic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
[00840516142500]
Radiation Sterilization;Ethylene Oxide
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-10-08 | 
| Device Publish Date | 2024-09-30 | 
| 00840516103457 | Sub Tenon Cannula 19g X 25mm (1") curved, flat tip | 
| 00840516103334 | Retrobulbar Needle [Atkinson] 23G X 38mm (1 1/2") | 
| 00840516103280 | Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2") | 
| 00840516103761 | Anterior Chamber Cannula 26g X 3mm bend | 
| 00840516103754 | Anterior Chamber Cannula 26g X 2mm bend | 
| 00840516103747 | Anterior Chamber Cannula 27g X 12mm bend | 
| 00840516103730 | Anterior Chamber Cannula 27g X 11mm bend | 
| 00840516103723 | Anterior Chamber Cannula 27g X 10mm bend | 
| 00840516103716 | Anterior Chamber Cannula 27g X 9mm bend | 
| 00840516103709 | Anterior Chamber Cannula 27g X 8mm bend | 
| 00840516103693 | Anterior Chamber Cannula 27g X 7mm bend | 
| 00840516103686 | Anterior Chamber Cannula 27g X 6mm bend | 
| 00840516103679 | Anterior Chamber Cannula 27g X 5mm bend | 
| 00840516103662 | Anterior Chamber Cannula 27g X 4mm bend | 
| 00840516103655 | Anterior Chamber Cannula 27g X 3mm bend | 
| 00840516103648 | Anterior Chamber Cannula 27g X 2mm bend | 
| 00840516103631 | Anterior Chamber Cannula 30g X 12mm bend | 
| 00840516103624 | Anterior Chamber Cannula 30g X 11mm bend | 
| 00840516103617 | Anterior Chamber Cannula 30g X 10mm bend | 
| 00840516103600 | Anterior Chamber Cannula 30g X 9mm bend | 
| 00840516103594 | Anterior Chamber Cannula 30g X 8mm bend | 
| 00840516103587 | Anterior Chamber Cannula 30g X 7mm bend | 
| 00840516103570 | Anterior Chamber Cannula 30g X 6mm bend | 
| 00840516103563 | Anterior Chamber Cannula 30g X 5mm bend | 
| 00840516103549 | Anterior Chamber Cannula 30g X 3mm bend | 
| 00840516103532 | Anterior Chamber Cannula 30g X 2mm bend | 
| 00840516103501 | Rous Sub Tenon/Parabulbar Needle 25g X 16mm (5/8"), extra sharp, curved | 
| 00840516103495 | Sub Tenon Cannula 19g X 25mm (1") 7mm angled tip, tri port | 
| 00840516103488 | Sub Tenon Cannula 19g X 25mm (1") curved, tri port | 
| 00840516103471 | Sub Tenon Cannula 21g X 22mm (7/8") 7mm angled tip, tri port | 
| 00840516103464 | Sub Tenon Cannula 21g X 22mm (7/8") curved, tri port | 
| 00840516103440 | Peribulbar Needle [Non Atkinson] 27g X 13mm (1/2") | 
| 00840516103433 | Peribulbar Needle [Non Atkinson] 22g X 25mm (1") | 
| 00840516103426 | Peribulbar Needle [Non Atkinson] 30g X 16mm (5/8") | 
| 00840516103419 | Peribulbar Needle [Non Atkinson] 27g X 16mm (5/8") | 
| 00840516103402 | Peribulbar Needle [Non Atkinson] 25g X 16mm (5/8") | 
| 00840516103396 | Peribulbar Needle [Non Atkinson] 23g X 16mm (5/8") | 
| 00840516103389 | Peribulbar Needle [Non Atkinson] 25g X 22mm (7/8") | 
| 00840516103372 | Peribulbar Needle [Non Atkinson] 25g X 25mm (1") | 
| 00840516103365 | Retrobulbar Needle [Non Atkinson] 27g X 38mm (1 1/2") | 
| 00840516103358 | Retrobulbar Needle [Non Atkinson] 26g X 38mm (1 1/2") | 
| 00840516103341 | Retrobulbar Needle [Non Atkinson] 25g X 38mm (1 1/2") | 
| 00840516103327 | Retrobulbar Needle [Atkinson] 23g X 38mm (1 1/2") | 
| 00840516103310 | Peribulbar Needle [Atkinson] 23g X 32mm (1 1/4") | 
| 00840516103303 | Peribulbar Needle [Atkinson] 23g X 22mm (7/8") | 
| 00840516103297 | Peribulbar Needle [Atkinson] 23g X 16mm (5/8") | 
| 00840516103273 | Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2") | 
| 00840516103266 | Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4") | 
| 00840516103259 | Peribulbar Needle [Atkinson] 25g X 22mm (7/8") | 
| 00840516103242 | Peribulbar Needle [Atkinson] 25g X 16mm (5/8") |