FDA.reportPublic FDA data

Hummingbird Tympanostomy Tube System

Primary DI
00853386007015
Brand
Hummingbird Tympanostomy Tube System
Company
PRECEPTIS MEDICAL, INC
Model
05-1001-501
Device description
05-1001-501, +90/-90 Inserter Assembly With Pre-loaded Vent Tube
Published
2017-08-31
Public version status
Update
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
ETDTube, Tympanostomy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142282000HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)Preceptis Medical2015-04-23ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853386007015PackageGS15In Commercial Distribution
00853386007008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853386007015008533860070158533860070150853386007015
00853386007008008533860070088533860070080853386007008

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 grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
011948777
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
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
00853386007053Hummingbird Tympanostomy Tube System05-1001-5022017-08-31
00853386007046Hummingbird Tympanostomy Tube System05-1001-5032017-08-31

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