FDA.reportPublic FDA data

Walcott Rx Products

Primary DI
00840285304321
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx0-170
Device description
IR/AR Cannula
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840285304321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285304321008402853043218402853043210840285304321

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)837-9875sales@walcottrx.com

Regulatory Flags#

DUNS number
837689694
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840285306899Walcott Rx ProductsRx4-0002022-08-10
00840285306905Walcott Rx ProductsRx4-000T2022-08-10
00840285306912Walcott Rx ProductsRx4-0012022-08-10
00840285306929Walcott Rx ProductsRx4-001T2022-08-10
00840285306936Walcott Rx ProductsRx4-0022022-08-10
00840285306943Walcott Rx ProductsRx4-0052022-08-10
00840285306950Walcott Rx ProductsRx4-005T2022-08-10
00840285306967Walcott Rx ProductsRx4-0062022-08-10
00840285306974Walcott Rx ProductsRx4-006T2022-08-10
00840285306981Walcott Rx ProductsRx4-0082022-08-10
00840285306998Walcott Rx ProductsRx4-0092022-08-10
00840285307001Walcott Rx ProductsRx4-009T2022-08-10
00840285307018Walcott Rx ProductsRx402S2022-08-10
00840285307025Walcott Rx ProductsRx4022022-08-10
00840285307032Walcott Rx ProductsRx4-0112022-08-10
00840285307049Walcott Rx ProductsRx4-011T2022-08-10
00840285307056Walcott Rx ProductsRx402SM2022-08-10
00840285307063Walcott Rx ProductsRx401S2022-08-10
00840285307070Walcott Rx ProductsRx401RS2022-08-10
00840285307087Walcott Rx ProductsRx401R2022-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
G412CA14030MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14040MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14050MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14070MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14080MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14090MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14100MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14110MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14120MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14130MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14140MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14150MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14160MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14170MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14180MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14190MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14200MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14210MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14220MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14230MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14240MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14250MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14260MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14270MR PHACOCrestpoint Management LimitedHMX2025-05-27