FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516131252
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
CL4004
Device description
McPherson Tying Forceps Straight 5mm Tying Platform, Three Hole Flat Handle, SS
Published
2023-07-25
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
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516131252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516131252008405161312528405161312520840516131252

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

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
G04320061G0GEIZBear-Ent, LLCHNR2026-05-26
G04320062G0GEIZBear-Ent, LLCHNR2026-05-26
G04320065G0GEIZBear-Ent, LLCHNR2026-05-26
G04320067G0GEIZBear-Ent, LLCHNR2026-05-26
G04320068G0GEIZBear-Ent, LLCHNR2026-05-26
00041533986522Bruder KarpeckiThe Hilsinger Company Parent, LlcHNR2026-05-22
04251047910340Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047910357Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047911675Utrata Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047913990Kelman-McPherson Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
04251047918261Castroviejo Needle HolderA1 Medical GmbHHNR2026-05-22
04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047925399Ergo Grip Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047928383Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047931581Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047932250Micro Gripping ForcepsA1 Medical GmbHHNR2026-05-22
04251047932281ILM ForcepsA1 Medical GmbHHNR2026-05-22
04251047933165SIGNUM LEHNER MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933189SIGNUM INAMURA MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047934407Alio MICS Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047934711Gerten DMEK Rhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047936418Gerten Iridectomy ForcepsA1 Medical GmbHHNR2026-05-22
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G346EA0323SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-03-12
00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06