FDA.reportPublic FDA data

Hummingbird Tympanostomy Tube System

Primary DI
00853386007084
Brand
Hummingbird Tympanostomy Tube System
Company
PRECEPTIS MEDICAL, INC
Model
05-1001-752
Catalog number
05-1001-752
Device description
05-1001-752, -90 Inserter With Pre-loaded 1.14mm ID Vent Tube
Published
2026-01-05
Public version status
New
Distribution status
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
50853386007089PackageGS110In Commercial Distribution
00853386007084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085338600708950853386007089
00853386007084008533860070848533860070840853386007084

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
833 327 8823customerservice@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
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
00853386007039Hummingbird Tympanostomy Tube System05-1001-5032017-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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