FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319722121
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
210-432
Catalog number
210-432
Device description
"Rubin Alar (Gunter) Morselizer 7"" (17.5cm), serrated tungsten carbide jaws"
Published
2022-08-08
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
KAEFORCEPS, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319722121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319722121008403197221218403197221210840319722121

GMDN Terms#

Term, Definition table
TermDefinition
Otologic clampA hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. 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
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
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901807evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903160evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903177evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903184evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903191evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903207evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905591evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905607evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905614evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905690evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905706evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905713evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905720evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905737evonosevonos GmbH & Co. KGKAE2026-08-21
04054462907670evonosevonos GmbH & Co. KGKAE2026-08-21
04054462907687evonosevonos GmbH & Co. KGKAE2026-08-21
04054462907694evonosevonos GmbH & Co. KGKAE2026-08-21
00190776417147MillenniumAvalign Technologies, Inc.KAE2026-08-19
04054462910793evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910823evonosevonos GmbH & Co. KGKAE2026-08-19
04054462910830evonosevonos GmbH & Co. KGKAE2026-08-19