FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319705407
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
190-314
Catalog number
190-314
Device description
"Billeau Flexible Ear Loop 6-1/2"" (16.3cm), small size #1"
Published
2022-07-27
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
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319705407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319705407008403197054078403197054070840319705407

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901647evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901654evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901661evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908141evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422356MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422363MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31
00190776403331MillenniumAvalign Technologies, Inc.JYG2026-07-21
00190776400637MillenniumAvalign Technologies, Inc.JYG2026-07-19
00190776395469MillenniumAvalign Technologies, Inc.JYG2026-07-14
09348811100603INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100825INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100832INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21