FDA.reportPublic FDA data

BEAR

Primary DI
B351B624010
Brand
BEAR
Company
Mytamed, Inc.
Model
6.24.01
Catalog number
6.24.01
Device description
McKenna Crimping Forceps with Spring
Published
2020-05-18
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
NNQForceps, Wire Closure, Ent, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNQForceps, Wire Closure, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B624010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT wire crimperA hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. 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
00887482112878Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.NNQ2024-08-20
00887482112755Symmetry McGeeASPEN SURGICAL PRODUCTS, INC.NNQ2024-08-06
00887482112779Symmetry McGeeASPEN SURGICAL PRODUCTS, INC.NNQ2024-08-06
G043624020BEARBear-Ent, LLCNNQ2023-01-26
G043624030BEARBear-Ent, LLCNNQ2023-01-26
04250381848739Fisch-McGee wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
04250381848746Greven wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
04250381849699McGee wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
04250381849705McGee wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
04250381850022McGee wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
04250676721068Müller wire closing forcepsSpiggle & Theis Medizintechnik GmbHNNQ2022-09-13
00887482055236Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.NNQ2022-08-25
G043624000BEARBear-Ent, LLCNNQ2022-06-08
G043624010BEARBear-Ent, LLCNNQ2022-06-08
B351624000mytaMedMytamed, Inc.NNQ2018-02-15
B351624010mytaMedMytamed, Inc.NNQ2018-02-15