FDA.reportPublic FDA data

Walcott Rx Products

Primary DI
00840285312395
Brand
Walcott Rx Products
Company
Walcott Rx Product Inc
Model
Rx6-035
Device description
Fixation Ring
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
HJBInstrument, measuring, corneal radius

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJBInstrument, Measuring, Corneal RadiusOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840285312395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840285312395008402853123958402853123950840285312395

GMDN Terms#

Term, Definition table
TermDefinition
Eyeball fixation instrument, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device.

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
00757770498680Bausch + LombBausch & Lomb IncorporatedHJB2025-08-04
00194613021016MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613039172MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613039189MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613087548MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613087586MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099558MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099572MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099589MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099718MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100056MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100414MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100469MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100568MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100667MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100735MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100803MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613101046MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613103187MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613113063MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613113070MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613001988MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00194613048914MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00194613087241MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00194613099701MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00194613099725MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00840285320451Walcott Rx ProductsWalcott Rx Product IncHJB2022-11-23
00840285320468Walcott Rx ProductsWalcott Rx Product IncHJB2022-11-23
00840285320321Walcott Rx ProductsWalcott Rx Product IncHJB2022-11-11
00840285311589Walcott Rx ProductsWalcott Rx Product IncHJB2022-08-10