FDA.reportPublic FDA data

BEAR

Primary DI
B351B810100
Brand
BEAR
Company
Mytamed, Inc.
Model
8.10.10
Catalog number
8.10.10
Device description
Laryngeal Mirror, Rhodium, EC 10 / US 9 (30mm)
Published
2020-05-19
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
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B810100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. 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
04054462902880evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902910evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902934evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902941evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902958evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902972evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902989evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902996evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903061evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903078evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903085evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902767evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902774evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902781evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902798evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902804evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902811evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902828evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902835evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902842evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902859evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902866evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902873evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902897evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902927evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903009evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903016evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18