FDA.report

Walcott Rx Products

Primary DI
00840285305205
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx7-021-10
Device description
Irrigating Handle
Published
2022-08-10
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

Related Records

Contact Domains

Product Codes

CodeName
HMXCannula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840285305205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285305205008402853052058402853052050840285305205

GMDN Terms

TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)837-9875sales@walcottrx.com

Regulatory Flags

DUNS number
837689694
Device count
1
DM exempt
true
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
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 DIBrandModelCatalogPublished
00840285320772Walcott Rx ProductsRx0-037-122025-03-28
00840285320765Walcott Rx ProductsRx4272024-11-22
00840285320758Walcott Rx ProductsRx302024-07-08
00840285320741Walcott Rx ProductsRx4-642T2024-06-24
00840285320734Walcott Rx ProductsRx901-5.752024-06-11
00840285320727Walcott Rx ProductsRx441FL2024-04-08
00840285320710Walcott Rx ProductsRx0-015-102024-03-25
00840285320697Walcott Rx ProductsRx902-8.52024-01-11
00840285320703Walcott Rx ProductsRx902-8.752024-01-11
00840285320680Walcott Rx ProductsRx0-2612023-09-22
00840285320673Walcott Rx ProductsRx4-242T2023-05-16
00840285320666Walcott Rx ProductsRx410S2023-05-09
00840285320659Walcott Rx ProductsRx4-2382023-04-03
00840285320642Walcott Rx ProductsRx0-2072023-03-24
00840285320543Walcott Rx ProductsRx3822022-12-07
00840285320550Walcott Rx ProductsRx3832022-12-07
00840285320567Walcott Rx ProductsRx0-10002022-12-07
00840285320574Walcott Rx ProductsRx418T2022-12-07
00840285320529Walcott Rx ProductsRx2692022-12-05
00840285320536Walcott Rx ProductsRx2692022-12-05

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