FDA.reportPublic FDA data

BEAR

Primary DI
B351B755000
Brand
BEAR
Company
Mytamed, Inc.
Model
7.55.00
Catalog number
7.55.00
Device description
Hildyard Post-Nasal Biopsy Forceps, 3.5mm Cups
Published
2021-11-18
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
KAXPunch, Ethmoid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAXPunch, EthmoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B755000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
G2231318720Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKAX2023-09-28
G043706480BEARBear-Ent, LLCKAX2022-11-07
G043706490BEARBear-Ent, LLCKAX2022-11-07
G043706930BEARBear-Ent, LLCKAX2022-10-24
G043707260BEARBear-Ent, LLCKAX2022-06-09
G043707270BEARBear-Ent, LLCKAX2022-06-09
G043707280BEARBear-Ent, LLCKAX2022-06-09
G043707290BEARBear-Ent, LLCKAX2022-06-09
G043707300BEARBear-Ent, LLCKAX2022-06-09
G043707310BEARBear-Ent, LLCKAX2022-06-09
G043755000BEARBear-Ent, LLCKAX2022-06-09
G043706100BEARBear-Ent, LLCKAX2022-06-08
G043706110BEARBear-Ent, LLCKAX2022-06-08
G043706120BEARBear-Ent, LLCKAX2022-06-08
G043706500BEARBear-Ent, LLCKAX2022-06-08
G043706510BEARBear-Ent, LLCKAX2022-06-08
G043706520BEARBear-Ent, LLCKAX2022-06-08
G043706530BEARBear-Ent, LLCKAX2022-06-08
G043706260BEARBear-Ent, LLCKAX2022-03-23
G043706270BEARBear-Ent, LLCKAX2022-03-23
G043706280BEARBear-Ent, LLCKAX2022-03-23
G043706290BEARBear-Ent, LLCKAX2022-03-23
G043706300BEARBear-Ent, LLCKAX2022-03-23
G043706310BEARBear-Ent, LLCKAX2022-03-23
G043706320BEARBear-Ent, LLCKAX2022-03-23
G043706330BEARBear-Ent, LLCKAX2022-03-23
G043706340BEARBear-Ent, LLCKAX2022-03-23
B351B706100BEARMytamed, Inc.KAX2021-10-25
B351B706110BEARMytamed, Inc.KAX2021-10-25
B351B706120BEARMytamed, Inc.KAX2021-10-25