FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586E7221480
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
E7221-48
Catalog number
E7221-48
Device description
rosen suction tube, 60.0 mm tube length, 17 gauge
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
G586E7221480PrimaryHIBCC0

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(877)860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770428588Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770676491Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770425044Bausch + LombBausch & Lomb IncorporatedJZF2026-02-04
00757770446629Bausch + LombBausch & Lomb IncorporatedJZF2025-12-12
09348811000743INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-12-02
00757770701230Bausch + LombBausch & Lomb IncorporatedJZF2025-11-16
00757770436842Bausch + LombBausch & Lomb IncorporatedJZF2025-11-14
04250676745668Suction tube with windowSpiggle & Theis Medizintechnik GmbHJZF2025-09-19
00757770452682Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
00757770680498Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
04250676740533Saxby-IrrigatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-11
04250676722539Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722546Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722553Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722560Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722577Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722584Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722591Panetti suction separatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722607Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722614Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676733153Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733160Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733177Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733184Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733191Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733207Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733214Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738547Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738554Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676742865Preyer dissector, sinus tympaniSpiggle & Theis Medizintechnik GmbHJZF2025-09-03