FDA.reportPublic FDA data

BEAR

Primary DI
G043280420
Brand
BEAR
Company
Bear-Ent, LLC
Model
2.80.42
Catalog number
2.80.42
Device description
Jackson-Trousseau Tracheal Dilator, Large
Published
2024-08-03
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
KCGDilator, Tracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043280420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, reusableA hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. 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
00190776399351MillenniumAvalign Technologies, Inc.KCG2025-05-30
04049047041818GimmiGimmi GmbHKCG2025-05-08
04049047700043GimmiGimmi GmbHKCG2025-05-08
00840183513764BR Surgical, LLCBR Surgical, LLCKCG2024-06-10
00888515246850BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246867BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246881BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
G586E98477130Novo SurgicalNOVO SURGICAL, INC.KCG2023-12-18
G25010005140Laborde Dilator ForcepN S SURGICAL COMPANYKCG2023-04-29
00842331179754Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-14
00842331160448Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-13
00842331139123Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-11
00842331136054Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-10
00887482049303Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482049310Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124123Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124130Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482002322Symmetry DelabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00887482002605Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00190776184469MillenniumAvalign Technologies, Inc.KCG2021-11-01
00190776184476MillenniumAvalign Technologies, Inc.KCG2021-11-01
04035324017263TRACOE experc Dilation SetTracoe medical GmbHKCG2021-03-05
04046826135782MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135799MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135805MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
10649111117039SklarSKLAR CORPORATIONKCG2019-03-13
10649111134012SklarSKLAR CORPORATIONKCG2019-03-13
10649111397165SklarSKLAR CORPORATIONKCG2019-03-13
10649111397172SklarSKLAR CORPORATIONKCG2019-03-13
10381780086499Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKCG2018-10-24