FDA.reportPublic FDA data

BEAR

Primary DI
B351B714020
Brand
BEAR
Company
Mytamed, Inc.
Model
7.14.02
Catalog number
7.14.02
Device description
Vienna Nasal Specula, No.2, Medium
Published
2020-05-18
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
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B714020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
G043608500BEARBear-Ent, LLCEPY2022-05-23
10381780503453Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503545Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780478591Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-18
10381780506300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-12
10381780403852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780418993Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419006Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16