FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319709795
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
335-005
Catalog number
335-005
Device description
"Needle Extender, 5"""
Published
2022-07-28
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
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319709795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319709795008403197097958403197097950840319709795

GMDN Terms#

Term, Definition table
TermDefinition
Luer needle extenderA slim, rigid tube intended to connect to a Luer needle to extend the length of the needle for access to anatomical sites that a standard length needle might not reach. It has a Luer connection at each end and does not incorporate any additional functionality. 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
00850084501012Xpansion® Micro-Autografting KitNEW HORIZON HEALTHCARE MANAGEMENT LLCGDF2026-07-28
06976712970334Hemo NeedleMicro-Energy Medical Technology Co., LtdGDF2026-07-13
04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
08056138586338MarkXM.D.L. S.R.L.GDF2025-02-28
08057276004715MarkXM.D.L. S.R.L.GDF2025-02-28
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199505767Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505774Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505798Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505804Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505811Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505828Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505835Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505842Needle HolderKOROS U.S.A., INC.GDF2022-04-01