FDA.reportPublic FDA data

ARMSTRONG VENT TUBE

Primary DI
10844505014042
Brand
ARMSTRONG VENT TUBE
Company
Grace Medical, Inc.
Model
525-501
Device description
ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K232059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232059000Tympanostomy TubesGrace Medical, Inc.2023-11-24ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844505014042PackageGS15In Commercial Distribution
00844505014045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450501404210844505014042
00844505014045008445050140458445050140450844505014045

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
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
00844505014625HOUGH FLAP KNIFE999-2042026-03-27
00844505014632THOMASSIN DISSECTOR999-2052026-03-27
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505012249EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.EE-03002019-12-05
00844505012256EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EE-03302019-12-05
00844505012263EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EE-03452019-12-05
00844505012270EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EE-03702019-12-05
00844505014694SKULL BASE999-SB12025-09-26
00844505014700SKULL BASE999-SB22025-09-26
00844505014717SKULL BASE999-SB52025-09-26
00844505014724SKULL BASE999-SB62025-09-26
00844505014502TITANIUM PISTON461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTON402-5502025-09-18
00844505014489ECLIPSE PISTON467-3502025-08-05
00844505014519TITANIUM PISTON460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTON402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTON402-5752025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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