FDA.report

Walcott Rx Products

Primary DI
00840516133010
Brand
Walcott Rx Products
Company
Psi/Eye-Ko, Inc.
Model
Rx5008
Device description
Irrigating Cystotome 27g X 16mm (5/8"), small radius
Published
2023-08-16
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

Product Codes

CodeName
HNYCystotome

Product Code Classifications

CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840516134581PrimaryGS10
00840516133010Unit of UseGS10

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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