N/A

GUDID 00763000578022

SPLINT 1528110 25PK EXTERNAL NASAL SMALL

MEDTRONIC XOMED, INC.

External nasal splint

Primary Device ID	00763000578022
NIH Device Record Key	2636fdd7-e27c-4ba6-a2cb-fd2c3927dd7a
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	1528110
Company DUNS	835465063
Company Name	MEDTRONIC XOMED, INC.
Device Count	25
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter
Width	5.7 Centimeter
Length	3.2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000578022 [Unit of Use]
GS1	20763000578026 [Primary]

FDA Product Code

EPP	SPLINT, NASAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-09-24
Device Publish Date	2024-09-16

On-Brand Devices [N/A]

20613994839637	INSTRUMENT WIPE 2218525 25PK 9CM X 9CM
00613994513953	PROBE 945CNP2002 100MM CONCENTRIC
00613994370075	BUR 31113065 3MM CRS DIAMOND MED LENGTH
00613994370068	BUR 31112565 2.5MM CRS DIAMD MED LENGTH
00613994370051	BUR 31112065 2MM CRS DIAMOND MED LENGTH
00613994370020	BUR 31133065 3MM FINE DIAMOND MED LENGTH
00613994370013	BUR 31132565 2.5MM FINE DIAMD MED LENGTH
00613994370006	BUR 31132065 2MM FINE DIAMD MED LENGTH
00613994369994	BUR 31131565 1.5MM FINE DIAMD MED LENGTH
00613994369987	BUR 31131066 1MM FINE DIAMD MED LENGTH
00613994369970	BUR 31130566 .5MM FINE DIAMD MED LENGTH
00613994369963	BUR 31313065UE ULTRA 3MM STEEL MED LGTH
00613994369956	BUR 31312565UE ULTRA 2.5MM STL MED LGTH
00613994369949	BUR 31312065 2MM STEEL MED LENGTH
00613994369932	BUR 31311565 1.5MM STEEL MED LENGTH
00613994369925	BUR 31311066 1MM STEEL MED LENGTH
00613994353184	BUR 31133565 3.5MM FINE DIAMD MED LENGTH
00613994353122	BUR 31113565 3.5MM CRS DIAMD MED LENGTH
00613994353023	BUR 31313565UE ULTRA 3.5MM STEEL MED L
00613994353016	BUR 31311075 1MM STEEL X-LONG
00613994353009	BUR 31311575 1.5MM STEEL X-LONG
00613994352996	BUR 31312075 2MM STEEL X-LONG
00613994352989	BUR 31312575 2.5MM STEEL X-LONG
00613994352972	BUR 31313075UE ULTRA 3MM STEEL X-LONG
00613994352965	BUR 31313575UE ULTRA 3.5MM STEEL X-LONG
00613994352958	BUR 31314075UE ULTRA 4MM STEEL X-LONG
20613994233329	BLADE 1884080HR 5PK TRICUT M4 13CM 4MM
00613994233233	BUR 1885078HSE 13CM X 5MM 70DEG DIAMOND
00613994233219	BUR 1883277HSE 15CM X 3.2MM 40DG DIAMOND
00613994233196	BUR 1885076HSE 15CM X 5MM 15DEG DIAMOND
00613994233189	BUR 1884075HSE 15CM X 4MM 15DEG CUTTING
00613994233165	BUR 1883274HSE 15CM X 3.2MM 15DG DIAMOND
00613994221476	BUR 31236058 6MM SST PEAR MED LENGTH
00613994221469	BUR 31255558 5.5MM SST OVAL MED LENGTH
00613994221421	BUR 31134065 4MM FINE DIAMOND MED LENGTH
00613994221414	BUR 31135059 5MM FINE DIAMOND MED LENGTH
00613994221407	BUR 31136058 6MM FINE DIAMOND MED LENGTH
00613994221391	BUR 31114065 4MM CRSE DIAMOND MED LENGTH
00613994221377	BUR 31115059 5MM CRSE DIAMOND MED LENGTH
00613994221360	BUR 31116058 6MM CRSE DIAMOND MED LENGTH
00613994102232	BUR 31314065UE ULTRA 4MM MED LENGTH
20613994102229	BUR 31314065U ULTRA 5PK 4MM MED LENGTH
00613994102218	BUR 31315059UE ULTRA 5MM MED LENGTH
20613994102205	BUR 31315059U ULTRA 5PK 5MM MED LENGTH
00613994102188	BUR 31316058UE ULTRA 6MM MED LENGTH
20613994102175	BUR 31316058U ULTRA 5PK 6MM MED LENGTH
00613994102164	BUR 31317057UE ULTRA 7MM MED LENGTH
20613994102151	BUR 31317057U ULTRA 5PK 7MM MED LENGTH
00613994097170	BUR 31135051 5MM FINE DIAMOND STD LENGTH
00643169938847	ELECTRODE 8227703 PRD NDL 22MM 8CH ROHS