Primary Device ID | 00840516121468 |
NIH Device Record Key | 7870ea14-a638-489b-8848-ba412bfcb393 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anodyne Surgical |
Version Model Number | 8209 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840516117607 [Primary] |
GS1 | 00840516121468 [Package] Contains: 00840516117607 Package: Bag [50 Units] In Commercial Distribution |
GS1 | 00840516125343 [Package] Contains: 00840516117607 Package: Bag [500 Units] In Commercial Distribution |
HNQ | Hook, Ophthalmic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
[00840516121468]
Radiation Sterilization;Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-07 |
Device Publish Date | 2023-08-30 |
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") |