FDA.reportPublic FDA data

BEAR

Primary DI
G043708010
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.08.01
Catalog number
7.08.01
Device description
Ferris-Smith Kerrison, 90 Deg. Up, 2.0mm
Published
2022-08-10
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
KBBRongeur, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043708010PrimaryHIBCC0

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
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08
G043111520BEAR1.11.521.11.522026-07-08
G043111540BEAR1.11.541.11.542026-07-08
G043111550BEAR1.11.551.11.552026-07-08
G043111560BEAR1.11.561.11.562026-07-08
G043111570BEAR1.11.571.11.572026-07-08
G043111580BEAR1.11.581.11.582026-07-08
G043111590BEAR1.11.591.11.592026-07-08
G043111600BEAR1.11.601.11.602026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811146069INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-07-03
09348811112323INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-03-18
09348811112347INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-03-18
09348811112484INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-01-28
09348811146052INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811172921INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811145970INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
09348811172914INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
00757770404759Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770407071Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770411979Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770425396Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770428632Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770430925Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770469475Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00190776407056MillenniumAvalign Technologies, Inc.KBB2025-07-28
08403207006042Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
08403207006059Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
00842331191404Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
G586E7373630Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
00190776044817AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776225421AvalignAvalign Technologies, Inc.KBB2023-11-13
00190776044824AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044831AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044848AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048334AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776048600AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776221102AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776320492MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320508MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28