FDA.reportPublic FDA data

JEDMED

Primary DI
M633310350SP10
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
31-0350-SP1
Catalog number
31-0350-SP1
Device description
PICK EAR DAY STRAIGHT
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
JYTPick, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M633310350SP10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
09348811111944INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-06-02
09348811150301INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150318INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150325INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150349INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150363INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150387INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150400INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150417INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
00190776421571MillenniumAvalign Technologies, Inc.JYT2026-05-05
09348811111975INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-04-24
09348811022677INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-18
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811111968INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811112019INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811155344INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811109828INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109835INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109842INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109859INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111913INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111920INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111937INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811150295INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
00190776413200MillenniumAvalign Technologies, Inc.JYT2025-10-09
G04365983B0BEARBear-Ent, LLCJYT2024-02-03
14026704804662PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804679PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804686PILLINGTELEFLEX INCORPORATEDJYT2022-12-08