FDA.reportPublic FDA data

EndoEar™ SUCTION

Primary DI
00844505012133
Brand
EndoEar™ SUCTION
Company
Grace Medical, Inc.
Model
1.85.03
Device description
EndoEar™ SUCTION LONG CURVE, 3 FR, UP STAINLESS STEEL
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844505012133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844505012133008445050121338445050121330844505012133

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844505014625HOUGH FLAP KNIFE999-2042026-03-27
00844505014632THOMASSIN DISSECTOR999-2052026-03-27
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505012249EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.EE-03002019-12-05
00844505012256EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EE-03302019-12-05
00844505012263EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EE-03452019-12-05
00844505012270EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EE-03702019-12-05
00844505014694SKULL BASE999-SB12025-09-26
00844505014700SKULL BASE999-SB22025-09-26
00844505014717SKULL BASE999-SB52025-09-26
00844505014724SKULL BASE999-SB62025-09-26
00844505014502TITANIUM PISTON461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTON402-5502025-09-18
00844505014489ECLIPSE PISTON467-3502025-08-05
00844505014519TITANIUM PISTON460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTON402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTON402-5752025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811000736INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-11-21
08904428724017OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724024OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724031OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724048OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724055OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428722853OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722877OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722891OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722907OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722914OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722921OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722938OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722945OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722952OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722969OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722976OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722983OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722990OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723003OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723010OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723027OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723034OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723041OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723058OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723065OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723072OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723089OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723096OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723102OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04