FDA.reportPublic FDA data

BEAR

Primary DI
G043624030
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.24.03
Catalog number
6.24.03
Device description
McGee Crimping Forceps, Large
Published
2023-01-26
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
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
G043624030PrimaryHIBCC0

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
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
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
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
B351B624010BEARMytamed, Inc.NNQ2020-05-18
B351624000mytaMedMytamed, Inc.NNQ2018-02-15
B351624010mytaMedMytamed, Inc.NNQ2018-02-15