FDA.reportPublic FDA data

N/A

Primary DI
20763000299136
Brand
N/A
Company
MEDTRONIC XOMED, INC.
Model
1528111
Device description
SPLINT 1528111 5PK EXTERNAL NASAL SMALL
Published
2021-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPPSPLINT, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPPSplint, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000299136PrimaryGS10
00763000299132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300029913620763000299136
00763000299132007630002991327630002991320763000299132

GMDN Terms#

Term, Definition table
TermDefinition
External nasal splintA rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.2Centimeter
Width5.7Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
835465063
Device count
5
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
04250381810255External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-28
04250381823668Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823675Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823682Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823699External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823705External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823712External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823729Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823736Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823743Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823750Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823767Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381809945External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809969External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809976External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809990External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810019External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810057External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810071External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810088External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810101External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810125External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810194External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810217External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810231External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849828External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849835External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849859External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381851029Set external aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381856338Equipment box for external nasal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-09