FDA.reportPublic FDA data

BEAR

Primary DI
G043656110
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.56.11
Catalog number
6.56.11
Device description
Rosen Ear Needle, Blunt Tip, Strong Curve
Published
2022-03-31
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
G043656110PrimaryHIBCC0

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
123551586
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
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08
G043111520BEAR1.11.521.11.522026-07-08
G043111540BEAR1.11.541.11.542026-07-08
G043111550BEAR1.11.551.11.552026-07-08
G043111560BEAR1.11.561.11.562026-07-08
G043111570BEAR1.11.571.11.572026-07-08
G043111580BEAR1.11.581.11.582026-07-08
G043111590BEAR1.11.591.11.592026-07-08
G043111600BEAR1.11.601.11.602026-07-08
G04320061G0GEIZ2.00.61.G2.00.61.G2026-05-26
G04320062G0GEIZ2.00.62.G2.00.62.G2026-05-26
G04320065G0GEIZ2.00.65.G2.00.65.G2026-05-26
G04320067G0GEIZ2.00.67.G2.00.67.G2026-05-26
G04320068G0GEIZ2.00.68.G2.00.68.G2026-05-26
G043200600BEAR2.00.602.00.602022-08-03
G043200610BEAR2.00.612.00.612022-08-03
G043200620BEAR2.00.622.00.622022-08-03
G043200630BEAR2.00.632.00.632022-08-03
G043200640BEAR2.00.642.00.642022-08-03

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