FDA.reportPublic FDA data

BEAR

Primary DI
B351B655100
Brand
BEAR
Company
Mytamed, Inc.
Model
6.55.10
Catalog number
6.55.10
Device description
House Measuring Rod, 3.5mm
Published
2021-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JYZRod, Measuring Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYZRod, Measuring EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B655100PrimaryHIBCC0

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
015903922
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
B351BMLGA4X6AC0BEARMLGA4X6ACMLGA4X6AC2021-02-09
B351BMLGA4X6ST0BEARMLGA4X6STMLGA4X6ST2021-02-09
B351BMLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2021-02-09
B351BMLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2021-02-09
B351BMLGO4X6AC0BEARMLGO4X6ACMLGO4X6AC2021-02-09
B351BMLGO4X6ST0BEARMLGO4X6STMLGO4X6ST2021-02-09
B351BMLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2021-02-09
B351BMLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2021-02-09
B351BMLGS4X6AC0BEARMLGS4X6ACMLGS4X6AC2021-02-09
B351BMLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7AC0mytaMedMLGA4X7ACMLGA4X7AC2021-02-09
B351MLGO4X7AC0mytaMedMLGO4X7ACMLGO4X7AC2021-02-09
B351MLGO4X7ST0mytaMedMLGO4X7STMLGO4X7ST2021-02-09
B351MLGS4X7AC0mytaMedMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7ST0mytaMedMLGA4X7STMLGA4X7ST2020-12-14
B351BMLGS4X6ST0BEARMLGS4X6STMLGS4X6ST2020-05-13
B351BMLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2020-05-13
B351MLGS4X7ST0mytaMedMLGS4X7STMLGS4X7ST2020-05-13
B351MLGA4X6AC0mytaMedMLGA4X6ACMLGA4X6AC2018-02-16
B351MLGA4X6ST0mytaMedMLGA4X6STMLGA4X6ST2018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676726889Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2025-09-24
04250676726865Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2024-11-11
00887482047644Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113790Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113806Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113813Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00842331191091Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
G586E7214780Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
00190776044275AvalignAvalign Technologies, Inc.JYZ2023-11-13
00190776044299AvalignAvalign Technologies, Inc.JYZ2023-09-28
00190776319571MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
00190776319588MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
G043655090BEARBear-Ent, LLCJYZ2023-08-08
G043655100BEARBear-Ent, LLCJYZ2023-08-08
00190776369729MillenniumAvalign Technologies, Inc.JYZ2023-02-22
14026704805188PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805195PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805201PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805193PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805186PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805209PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805218PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
00842331174711Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00842331179525Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00840343700584Gen2SURGIX MEDICAL LLCJYZ2022-10-18
G277G2E9009610Gen2SURGIX MEDICAL LLCJYZ2022-09-23
04250676726872Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2022-09-12
00190776044282AvalignAvalign Technologies, Inc.JYZ2021-11-03
00190776044305AvalignAvalign Technologies, Inc.JYZ2021-11-03
B351B655110BEARMytamed, Inc.JYZ2021-11-01