FDA.reportPublic FDA data

BEAR

Primary DI
G043706270
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.06.27
Catalog number
7.06.27
Device description
Weil-Blakesley Forceps, 2.5mm, 45 Degree
Published
2022-03-23
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
G043706270PrimaryHIBCC0

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
G043615080BEAR6.15.086.15.082026-01-19
G043615090BEAR6.15.096.15.092026-01-19
G043615100BEAR6.15.106.15.102026-01-19
G043617010BEAR6.17.016.17.012022-09-24
G043617020BEAR6.17.026.17.022022-09-24
G043617030BEAR6.17.036.17.032022-09-24
G043617040BEAR6.17.046.17.042022-09-24
G043617050BEAR6.17.056.17.052022-09-24
G043618010BEAR6.18.016.18.012022-07-26
G043615010BEAR6.15.016.15.012022-06-12
G043615020BEAR6.15.026.15.022022-06-12
G043615030BEAR6.15.036.15.032022-06-12
G043615050BEAR6.15.056.15.052022-06-12
G043615060BEAR6.15.066.15.062022-06-12
G043616010BEAR6.16.016.16.012022-06-12
G043616020BEAR6.16.026.16.022022-06-12
G043616030BEAR6.16.036.16.032022-06-12
G043237270BEAR2.37.272.37.272026-08-21
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08

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
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