FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319758007
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
365-405
Catalog number
365-405
Device description
Masson-Holds Fascia Lata Stripper
Published
2025-04-30
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
HRTSTRIPPER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319758007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319758007008403197580078403197580070840319758007

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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(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
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
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12
00840319758892Hayden MedicalE7-0226E7-02262026-03-31
00840319758922Hayden MedicalE7-2234E7-22342026-03-31
00840319758939Hayden Medical210-179210-1792026-03-31
00840319758885Hayden MedicalE5-6271E5-62712026-03-27
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
00840319737798Hayden Medical105-432105-4322023-03-17
00840319733134Hayden Medical105-432-10105-432-102022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445944728SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944735SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944742SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944759SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944766SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944773SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944780SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944797SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944827SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944834SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304495SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304501SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304518SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346211SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346235SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346242SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
00190776419929MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776419936MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416249MillenniumAvalign Technologies, Inc.HRT2026-02-12
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462573N/ADoppkon GmbH & Co. KGHRT2025-12-01
04262494462559N/ADoppkon GmbH & Co. KGHRT2025-11-28
B7685410380Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
B7685410410Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
00816342024488STRIPPER, SURGICALPARCUS MEDICAL LLCHRT2025-09-16