FDA.reportPublic FDA data

DONALDSON VENT TUBE

Primary DI
00844505007672
Brand
DONALDSON VENT TUBE
Company
Grace Medical, Inc.
Model
510-011C
Device description
DONALDSON VENT TUBE 1.14MM ID PC SILICONE 5 PACK
Published
2016-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062672000GRACE MEDICAL PC COATED TYMPANOSTOMY TUBESGrace Medical, Inc.2006-10-24ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844505007679PackageGS15In Commercial Distribution
00844505007672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450500767910844505007679
00844505007672008445050076728445050076720844505007672

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
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844505014762BONE WAX APPLICATOR900-0012026-08-27
00844505012508Cartilage MACROTOME Handle990-1032021-10-29
00844505012515Cartilage MACROTOME Module990-1042021-10-29
00844505012522Cartilage MACROTOME Tissue Support990-1062021-10-29
00844505007139CARTILAGE MICROTOME990-0012018-09-21
00844505009010CARTILAGE MICROTOME MODULE990-0042018-09-21
00844505010399CARTILAGE MICROTOME HANDLE990-0032018-09-21
00844505010405TISSUE SUPPORT DIAL990-0062018-09-21
00844505014786FEATHERVAC, ECLIPSE906-1022026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBON906-1032026-08-18
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

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