FDA.reportPublic FDA data

N/A

Primary DI
00763000039899
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
1419020
Device description
COLLECTOR 1419020 10PK TYMPANOCENTESIS
Published
2020-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
20763000039893PrimaryGS10
00763000039899Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300003989320763000039893
00763000039899007630000398997630000398990763000039899

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical aspiratorA sterile hand-held device intended to be used to aspirate fluid from a ENT cavity (e.g., middle ear) during a single surgical procedure. It typically consists of a flexible tube inserted into the cavity, a collection container and a connection to the wall outlet of a central vacuum system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
10
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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