FDA.reportPublic FDA data

EndoEar™ SUCTION

Primary DI
00844505012027
Brand
EndoEar™ SUCTION
Company
Grace Medical, Inc.
Model
1.81.24
Device description
EndoEar™ SUCTION SHORT CURVE, 24 GA, 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
00844505012027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844505012027008445050120278445050120270844505012027

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
G043111500BEARBear-Ent, LLCJZF2026-07-08
G043111510BEARBear-Ent, LLCJZF2026-07-08
G043111520BEARBear-Ent, LLCJZF2026-07-08
G043111540BEARBear-Ent, LLCJZF2026-07-08
G043111550BEARBear-Ent, LLCJZF2026-07-08
G043111560BEARBear-Ent, LLCJZF2026-07-08
G043111570BEARBear-Ent, LLCJZF2026-07-08
G043111580BEARBear-Ent, LLCJZF2026-07-08
G043111590BEARBear-Ent, LLCJZF2026-07-08
G043111600BEARBear-Ent, LLCJZF2026-07-08
05060212053466Barron Suction Handle (3Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053473Barron Suction Handle (4Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053480Barron Suction Handle (5Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053497Barron Suction Handle (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053503Barron Suction Handle (7Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053534Micro Laryngeal Suction Handle 280mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053541Micro Laryngeal Suction Handle 330mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053558Micro Laryngeal Suction Handle 330mm x 3mm OD (9Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053565Micro Laryngeal Suction Handle, 360mm x 3mm OD (9Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053572Bronchoscopy Suction Handle 450mm x 4mm OD (12Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053589Oesophageal Suction Handle 550mm x 4mm OD (12Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060411982482Micro Laryngeal Suction Handle 240mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060411984288Curved Endoscopic Suction Tube, 3mm Bend Radius, 18 swgDTR MEDICAL LIMITEDJZF2026-06-10
05060411984301Curved Endoscopic Suction Tube, 6mm Bend Radius, 18 swgDTR MEDICAL LIMITEDJZF2026-06-10
00348783011388Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011395Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011401Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011418Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011425Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
09348811000736INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-11-21