Anodyne Surgical

GUDID 00840516113692

PVA Spear

Psi/Eye-Ko, Inc.

Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge Ophthalmic sponge
Primary Device ID00840516113692
NIH Device Record Key82f76008-6e7f-42b2-b9b1-c98fa561242c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnodyne Surgical
Version Model NumberFA01-0101-0520
Company DUNS063763833
Company NamePsi/Eye-Ko, Inc.
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com
Phone1(800)428-5628
Emailinfo@anodynesurgical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840516113692 [Unit of Use]
GS100840516113708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HOZSponge, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

[00840516113692]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

On-Brand Devices [Anodyne Surgical]

00840516103457Sub Tenon Cannula 19g X 25mm (1") curved, flat tip
00840516103334Retrobulbar Needle [Atkinson] 23G X 38mm (1 1/2")
00840516103280Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2")
00840516103761Anterior Chamber Cannula 26g X 3mm bend
00840516103754Anterior Chamber Cannula 26g X 2mm bend
00840516103747Anterior Chamber Cannula 27g X 12mm bend
00840516103730Anterior Chamber Cannula 27g X 11mm bend
00840516103723Anterior Chamber Cannula 27g X 10mm bend
00840516103716Anterior Chamber Cannula 27g X 9mm bend
00840516103709Anterior Chamber Cannula 27g X 8mm bend
00840516103693Anterior Chamber Cannula 27g X 7mm bend
00840516103686Anterior Chamber Cannula 27g X 6mm bend
00840516103679Anterior Chamber Cannula 27g X 5mm bend
00840516103662Anterior Chamber Cannula 27g X 4mm bend
00840516103655Anterior Chamber Cannula 27g X 3mm bend
00840516103648Anterior Chamber Cannula 27g X 2mm bend
00840516103631Anterior Chamber Cannula 30g X 12mm bend
00840516103624Anterior Chamber Cannula 30g X 11mm bend
00840516103617Anterior Chamber Cannula 30g X 10mm bend
00840516103600Anterior Chamber Cannula 30g X 9mm bend
00840516103594Anterior Chamber Cannula 30g X 8mm bend
00840516103587Anterior Chamber Cannula 30g X 7mm bend
00840516103570Anterior Chamber Cannula 30g X 6mm bend
00840516103563Anterior Chamber Cannula 30g X 5mm bend
00840516103549Anterior Chamber Cannula 30g X 3mm bend
00840516103532Anterior Chamber Cannula 30g X 2mm bend
00840516103501Rous Sub Tenon/Parabulbar Needle 25g X 16mm (5/8"), extra sharp, curved
00840516103495Sub Tenon Cannula 19g X 25mm (1") 7mm angled tip, tri port
00840516103488Sub Tenon Cannula 19g X 25mm (1") curved, tri port
00840516103471Sub Tenon Cannula 21g X 22mm (7/8") 7mm angled tip, tri port
00840516103464Sub Tenon Cannula 21g X 22mm (7/8") curved, tri port
00840516103440Peribulbar Needle [Non Atkinson] 27g X 13mm (1/2")
00840516103433Peribulbar Needle [Non Atkinson] 22g X 25mm (1")
00840516103426Peribulbar Needle [Non Atkinson] 30g X 16mm (5/8")
00840516103419Peribulbar Needle [Non Atkinson] 27g X 16mm (5/8")
00840516103402Peribulbar Needle [Non Atkinson] 25g X 16mm (5/8")
00840516103396Peribulbar Needle [Non Atkinson] 23g X 16mm (5/8")
00840516103389Peribulbar Needle [Non Atkinson] 25g X 22mm (7/8")
00840516103372Peribulbar Needle [Non Atkinson] 25g X 25mm (1")
00840516103365Retrobulbar Needle [Non Atkinson] 27g X 38mm (1 1/2")
00840516103358Retrobulbar Needle [Non Atkinson] 26g X 38mm (1 1/2")
00840516103341Retrobulbar Needle [Non Atkinson] 25g X 38mm (1 1/2")
00840516103327Retrobulbar Needle [Atkinson] 23g X 38mm (1 1/2")
00840516103310Peribulbar Needle [Atkinson] 23g X 32mm (1 1/4")
00840516103303Peribulbar Needle [Atkinson] 23g X 22mm (7/8")
00840516103297Peribulbar Needle [Atkinson] 23g X 16mm (5/8")
00840516103273Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2")
00840516103266Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4")
00840516103259Peribulbar Needle [Atkinson] 25g X 22mm (7/8")
00840516103242Peribulbar Needle [Atkinson] 25g X 16mm (5/8")
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