FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516131429
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
CI1003
Device description
Sinskey II Lens Hook .2mm Blunt tip, Angled 10mm, Flat Handle, 115mm Length, SS
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516131429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516131429008405161314298405161314290840516131429

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, reusableA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Radiation Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1(800)428-5628info@anodynesurgical.com

Regulatory Flags#

DUNS number
063763833
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
00840516142654Anodyne Surgical9903-8FSP2025-06-12
00840516142685Anodyne SurgicalCB30012025-02-28
00840516142661Anodyne SurgicalCI10052025-01-30
00840516142678Anodyne SurgicalCI10092025-01-30
00840516142579Anodyne SurgicalCG10052025-01-10
00840516142562Anodyne SurgicalCG10042024-12-12
00840516142555Anodyne SurgicalAFK-00072024-10-25
00840516142463Anodyne SurgicalCL50012024-09-30
00840516142470Anodyne SurgicalCX10012024-09-30
00840516142487Anodyne SurgicalCB20102024-09-30
00840516142494Anodyne SurgicalCB20092024-09-30
00840516142500Anodyne SurgicalCQ10022024-09-30
00840516141190Anodyne Surgical5004BFT2024-08-15
00840516142401Anodyne SurgicalCG10032024-08-02
00840516141923Anodyne SurgicalAFK-00012024-04-26
00840516141930Anodyne SurgicalAFK-00022024-04-26
00840516142005Anodyne SurgicalAFK-00032024-04-26
00840516142159Anodyne SurgicalAFK-00042024-04-26
00840516142166Anodyne SurgicalAFK-00052024-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417581MillenniumAvalign Technologies, Inc.HNQ2026-03-04
00810123209828Adler Instrument CompanyAdler, Inc.HNQ2026-02-10
00190776415662MillenniumAvalign Technologies, Inc.HNQ2026-02-02
00840319758663Hayden MedicalHayden Medical, Inc.HNQ2026-01-30
00190776415211MillenniumAvalign Technologies, Inc.HNQ2026-01-27
00840319758557Hayden MedicalHayden Medical, Inc.HNQ2025-12-31
G2231394680Sinskey lens manipulating hookMedetz Surgical Instruments LLCHNQ2025-12-16
00852194002076HAI HookHightech American Industrial Labs IncHNQ2025-12-15
09348811119902INKAThe Trustee for KAISER FAMILY TRUSTHNQ2025-12-03
00757770636228Bausch + LombBausch & Lomb IncorporatedHNQ2025-11-14
00757770645732Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00757770683666Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00840319758250Hayden MedicalHayden Medical, Inc.HNQ2025-09-12
00840319758229Hayden MedicalHayden Medical, Inc.HNQ2025-08-29
00757770421701Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-22
00757770636884Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
00757770673964Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
G22312244990Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G2231458300Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G223997034050Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00757770478613Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770507481Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770510962Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535514Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535682Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00194613004224MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004446MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004453MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004583MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004590MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01