FDA.reportPublic FDA data

JEDMED

Primary DI
M6335457790
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
54-5779
Catalog number
54-5779
Device description
FORCEPS GOITER LAHEY
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M6335457790PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body extraction forcepsA hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also include a magnifying lens and/or light source. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03

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