FDA.report

American Medicals

Primary DI
B356FB130100
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JZFTube, Ear Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B356FB130100PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods

Method
Microwave Radiation

Regulatory Flags

DUNS number
109909627
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
B356JD259280American Medicals12026-03-09
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356KD932040American Medicals12025-09-18
B356KD932070American Medicals12025-09-18
B356KE334280American Medicals12025-09-15
B356KJ522130American Medicals12025-09-12
B356FF131030American Medicals12025-08-16
B356FF131050American Medicals12025-08-16
B356KE292350American Medicals12025-08-15
B356KE295040American Medicals12025-08-15
B356KE296030American Medicals12025-08-15
B356KE312070American Medicals12025-08-15
B356KE328060American Medicals12025-08-15

Other Devices Sharing Product Codes

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