FDA.report

Hayden Medical

Primary DI
00840319722985
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
285-332
Catalog number
285-332
Device description
Walther Female Dilator-Catheter 5-1/4" (13.1cm), 32Fr. (10.6mm)
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319722985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319722985008403197229858403197229850840319722985

GMDN Terms

TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
Device count
1
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
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
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24
00840319758502Hayden Medical120-126D120-126D2025-12-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00194613046514MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100438MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613100766MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103057MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613103552MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104238MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613104993MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613105587MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106614MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613106942MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115913MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115920MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00194613115937MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-08-01
00190776394189MillenniumAvalign Technologies, Inc.FBX2025-05-07
00190776394196MillenniumAvalign Technologies, Inc.FBX2025-05-07
00840183530037BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530044BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530051BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530068BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530075BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530082BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530099BR Surgical, LLCBR Surgical, LLCFBX2025-04-16
00840183530020BR Surgical, LLCBR Surgical, LLCFBX2025-04-15
00840183529789BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00840183529864BR Surgical, LLCBR Surgical, LLCFBX2025-04-07
00194613046507MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613100773MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613103545MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613104221MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21
00194613105006MSI Precision Specialty InstrumentsMed Saver, Inc.FBX2025-03-21