FDA.reportPublic FDA data

N/A

Primary DI
00681490038263
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
1352237
Device description
INSERTER 1352237 E/Z LOAD T TUBE
Published
2017-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYMINSERTER, MYRINGOTOMY TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYMInserter, Myringotomy TubeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490038263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490038263006814900382636814900382630681490038263

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tube inserterA device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as myringotomy tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
00643169644786Otomag™ Attract™ Magnetic SpacerS0266-212016-04-15
00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15
00643169644830Otomag™ Attract™ Magnetic SpacerS0542-042016-04-15
00643169644847Otomag™ Attract™ Magnetic SpacerS0542-052016-04-15
00643169644854Otomag™ Attract™ Magnetic SpacerS0542-062016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183521844BR Surgical, LLCBR Surgical, LLCJYM2024-06-10
10381780074496Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-09-17
10381780391326Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391340Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856011Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856061Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
00681490038270N/AMEDTRONIC XOMED, INC.JYM2017-09-10