FDA.reportPublic FDA data

BEAR

Primary DI
G043662100
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.62.10
Catalog number
6.62.10
Device description
Farabeuf Periosteal Rasp, 15cm, Straight
Published
2025-10-08
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
KBARasp, Nasal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043662100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
00190776424039MillenniumAvalign Technologies, Inc.KBA2026-08-27
09348811103291INKAThe Trustee for KAISER FAMILY TRUSTKBA2026-07-31
00190776400491MillenniumAvalign Technologies, Inc.KBA2026-07-17
00810220800256Adler Instrument CompanyAdler, Inc.KBA2026-05-26
00190776420147MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420154MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420161MillenniumAvalign Technologies, Inc.KBA2026-04-16
14026704941688PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
24026704941685PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
09348811102744INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103246INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103253INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103260INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
04250676732187Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676732194Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676740229Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
04250676740236Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
00190776409920MillenniumAvalign Technologies, Inc.KBA2025-09-08
00194613032586MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032616MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032623MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032647MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032661MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032685MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613047887MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110314MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110321MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613111236MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613116941MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117115MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01