FDA.reportPublic FDA data

Pope

Primary DI
00681490031899
Brand
Pope
Company
MEDTRONIC XOMED, INC.
Model
1056036
Device description
VENT TUBE 1056036 5PK POPE HC-FLEX 1.14
Published
2015-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETDTUBE, TYMPANOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490031893PackageGS15Not in Commercial Distribution
00681490031899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149003189320681490031893
00681490031899006814900318996814900318990681490031899

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

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
M6333816500JEDMEDJEDMED INSTRUMENT COMPANYETD2023-05-08
00385640073509NASummit Medical, Inc.ETD2023-01-11
00385640068604Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068611Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068628Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068635Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068659Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068666Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068673Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068680Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068697Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068703Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068710Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068727Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068734Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068741Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068758Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068765Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068796Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068802Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068819Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068826Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068833Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068840Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068857Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068864Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068871Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068888Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068895Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068901Summit MedicalSummit Medical, Inc.ETD2022-10-06