FDA.reportPublic FDA data

JEDMED

Primary DI
M63334170280
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
34-1702 8
Catalog number
34-1702 8
Device description
CLAMP OSSICLE HOLDING DERLACKI
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYFClamp, Ossicle Holding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYFClamp, Ossicle HoldingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M63334170280PrimaryHIBCC0

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770417766Bausch + LombBausch & Lomb IncorporatedJYF2025-08-08
00840183524562BR Surgical, LLCBR Surgical, LLCJYF2024-05-28
G586E7216220Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
G586E7216230Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
00190776318925MillenniumAvalign Technologies, Inc.JYF2023-06-23
14026704805621PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805629PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
00887482043752Symmetry SheehyASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00887482114407Symmetry DerlackiASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00190660014919Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
00190660017767Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
04046964588204AESCULAPAESCULAP, INC.JYF2020-05-08
04046964589386AESCULAPAESCULAP, INC.JYF2020-05-08
10381780081258Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780081265Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780074564Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-09-17
10885403012242V. MuellerSTERIS CORPORATIONJYF2018-08-02
10381780190165Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
M2743854401Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
10381780458333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02
M2743854301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02