FDA.reportPublic FDA data

BEAR

Primary DI
G043106010
Brand
BEAR
Company
Bear-Ent, LLC
Model
1.06.01
Catalog number
1.06.01
Device description
Andrews-Pynchon Suction w Tip
Published
2022-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction
KCBTube, Tonsil Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043106010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
B382SD9114061030Surgical DirectSurgical Direct, Inc.KCB2026-07-23
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
00190776403959MillenniumAvalign Technologies, Inc.JOL2026-07-22
00190776403966MillenniumAvalign Technologies, Inc.JOL2026-07-22
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
00846159040678SCANLAN® Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
10888277407954MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-07-17
00840183531690BR Surgical, LLCBR Surgical, LLCKCB2026-07-16