FDA.reportPublic FDA data

BEAR

Primary DI
G043706490
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.06.49
Catalog number
7.06.49
Device description
Takahashi Nasal Forceps, 2.0mm, 45 Degree
Published
2022-11-07
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
KAXPunch, Ethmoid

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043706490PrimaryHIBCC0

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
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
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
G043200650BEAR2.00.652.00.652022-08-03
G043200660BEAR2.00.662.00.662022-08-03
G043200670BEAR2.00.672.00.672022-08-03
G043200680BEAR2.00.682.00.682022-08-03
G043MLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2022-05-19
G043MLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2022-05-19
G043MLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2022-05-19
G043MLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2022-05-19
G043MLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2022-05-19
G043MLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2022-05-19

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
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
B351B755000BEARMytamed, Inc.KAX2021-11-18
B351B706100BEARMytamed, Inc.KAX2021-10-25
B351B706110BEARMytamed, Inc.KAX2021-10-25
B351B706120BEARMytamed, Inc.KAX2021-10-25