FDA.reportPublic FDA data

Hummingbird Tympanostomy Tube System

Primary DI
00853386007039
Brand
Hummingbird Tympanostomy Tube System
Company
PRECEPTIS MEDICAL, INC
Model
05-1001-503
Device description
05-1001-503, -90/-90 Inserter Assembly With Pre-loaded Vent Tube
Published
2017-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00853386007046PackageGS15Not in Commercial Distribution
00853386007039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853386007046008533860070468533860070460853386007046
00853386007039008533860070398533860070390853386007039

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.

Contacts#

Phone, Email table
PhoneEmail
(763) 568-7810customerservice@preceptismedical.com

Regulatory Flags#

DUNS number
011948777
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853386007084Hummingbird Tympanostomy Tube System05-1001-75205-1001-7522026-01-05
00853386007091Hummingbird Tympanostomy Tube System05-1001-75305-1001-7532026-01-05
50853386007089Hummingbird Tympanostomy Tube System05-1001-75205-1001-7522026-01-05
50853386007096Hummingbird Tympanostomy Tube System05-1001-75305-1001-7532026-01-05
00853386007060Hummingbird Tympanostomy Tube System05-1001-65205-1001-6522021-04-12
00853386007077Hummingbird Tympanostomy Tube System05-1001-65305-1001-6532021-04-12
00853386007008Hummingbird Tympanostomy Tube System05-1001-5012017-08-31
00853386007022Hummingbird Tympanostomy Tube System05-1001-5022017-08-31
50853386007065Hummingbird Tympanostomy Tube System05-1001-65205-1001-6522021-04-12
50853386007072Hummingbird Tympanostomy Tube System05-1001-65305-1001-6532021-04-12
00853386007015Hummingbird Tympanostomy Tube System05-1001-5012017-08-31
00853386007053Hummingbird Tympanostomy Tube System05-1001-5022017-08-31
00853386007046Hummingbird Tympanostomy Tube System05-1001-5032017-08-31

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Primary DI, Brand, Company table
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