FDA.reportPublic FDA data

Doyle II ™

Primary DI
20681490041892
Brand
Doyle II ™
Company
MEDTRONIC XOMED, INC.
Model
1524050
Device description
SPLINT 1524050 5PK PAIR DOYLE II AIRWAY
Published
2017-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASPLINT, INTRANASAL SEPTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20681490041892PackageGS15In Commercial Distribution
00681490041898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068149004189220681490041892
00681490041898006814900418986814900418980681490041898

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use 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
5
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16975560670271Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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06975560670090Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670100Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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