FDA.report

Walcott Rx Products

Primary DI
00840516133140
Brand
Walcott Rx Products
Company
Psi/Eye-Ko, Inc.
Model
Rx5109A
Device description
Nichamin Hydrodissection Cannula 25g (Formed)
Published
2023-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840516134710PrimaryGS10
00840516133140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516134710008405161347108405161347100840516134710
00840516133140008405161331408405161331400840516133140

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
1(800)428-5628info@anodynesurgical.com

Regulatory Flags

DUNS number
063763833
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
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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

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