FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319757758
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
405-191LS
Catalog number
405-191LS
Device description
Ferriera Style Breast Retractor 230mm x 13mm w/ Fiberoptic Light & Suction Tube (Smooth End)
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319757758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319757758008403197577588403197577580840319757758

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic retractor handleA hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgical sites typically during abdominal or pelvic surgical procedures. The fibreoptic bundle is attached to a separate light source, typically via a light-source cable, to produce illumination. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319759400Hayden Medical405-753405-7532026-09-04
00840319759417Hayden Medical405-754405-7542026-09-04
00840319759424Hayden Medical405-374405-3742026-09-04
00840319759431Hayden Medical100-405SCK100-405SCK2026-09-04
00840319759325Hayden Medical115-070H115-070H2026-08-27
00840319759332Hayden Medical115-070115-0702026-08-25
00840319758229Hayden MedicalE3-2617E3-26172025-08-29
00840319759271Hayden MedicalE7-2157E7-21572026-08-14
00840319759202Hayden MedicalE5-6408E5-64082026-07-30
00840319759189Hayden MedicalE7-2134E7-21342026-06-24
00840319759035Hayden MedicalPWT1064PWT10642026-06-10
00840319759042Hayden MedicalH-1004H-10042026-06-04
00840319759059Hayden MedicalH-1004H-10042026-06-04
00840319759066Hayden MedicalH-20012026-06-04
00840319759073Hayden MedicalH-1002H-10022026-06-04
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00192896123670Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00190776423902MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427443MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427450MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427467MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427474MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427481MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427498MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427504MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427511MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427528MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427535MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427658MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427702MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427719MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427726MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427818MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776420291MillenniumAvalign Technologies, Inc.GAD2026-08-25
G453FCE2004SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25
G453FCE2005SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25