SLIDE-ON®

GUDID 20874485000756

SHEATH 035102 10PK 1.5MM TNE-5000

MEDTRONIC XOMED, INC.

Optical medical device procedural cover

• Primary Device ID: 20874485000756
• NIH Device Record Key: 4a58ff4e-de94-4276-976a-fa059ed4a567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLIDE-ON®
• Version Model Number: 035102
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter
• Outer Diameter: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00874485000752 [Primary]
GS1	20874485000756 [Package]; Contains: 00874485000752; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071903

FDA Product Code

• EOX: ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-04-23

On-Brand Devices [SLIDE-ON®]

• 20613994657828: SHEATH 445601 10PK SENSORY ENT-5000
• 20613994657811: SHEATH 335601 10PK CHANNEL ENT-5000
• 20613994657798: SHEATH 035102 10PK 1.5MM TNE-5000
• 20613994657781: SHEATH 035101 10PK 2.1MM TNE-5000
• 20613994394808: SHEATH 336301 10PK CHNL STORZ 11101 RP
• 20613994394792: SHEATH 335401 10PK CHL VSI ENT2000/PX10S
• 20613994394785: SHEATH 335301 10PK CHANNEL MACH ENT-3L
• 20613994394778: SHEATH 335201 10PK CHANNEL VSI E-F100
• 20613994394761: SHEATH 334401 10PK CHANNEL OLYMPUS P4
• 20613994394754: SHEATH 334301 10PK CHANNEL OLYMPUS P3/P2
• 20613994394747: SHEATH 332401 10PK CHL PX 13S 1330/MA 4L
• 20613994394730: SHEATH 226301 20PK STORZ 11101 RP
• 20613994394723: SHEATH 226101 20PK STORZ SK1
• 20613994394716: SHEATH 225401 20PK VSI ENT-2000/PNTX 10S
• 20613994394709: SHEATH 225301 20PK VSI E-F100/MACH ENT3L
• 20613994394693: SHEATH 225101 20PK ENT 1000
• 20613994394686: SHEATH 224401 20PK OLYMPUS P4
• 20613994394679: SHEATH 224301 20PK OLYMPUS P3/P2
• 20613994394662: SHEATH 222401 20PK PTX FNL13S/MACH ENT4L
• 20613994394655: SHEATH 336401 10PK CHNL 11101RP1/EF-NS
• 20613994394648: SHEATH 445101 10PK SENSORY ENT-1000
• 20613994394631: SHEATH 032104 10PK TNE BX DIAGNOSTIC
• 20613994394624: SHEATH 226401 20PK STORZ RP1
• 20613994394617: SHEATH 225501 20PK PNTX VNL1170K/VNL1130
• 20613994394600: SHEATH 224501 20PK OLYMPUS ENF-V
• 20613994394594: SHEATH 224101 20PK OLYMPUS ENF-XP
• 20613994394587: SHEATH 222101 20PK MACHIDA ENT-2L
• 20613994394570: SHEATH 032102 10PK TNE-BX ENDOSHEATH
• 20613994394556: SHEATH 446301 10PK SENS STORZ 11101 RP
• 20613994394549: SHEATH 445401 10PK SENS ENT-2000/PX 10S
• 20613994394532: SHEATH 445301 10PK SENS E-F100/MA ENT3L
• 20613994394525: SHEATH 444401 10PK SENS OLYMPUS P4
• 20613994394518: SHEATH 444301 10PK SENS OLYMPUS P3/P2
• 20613994394501: SHEATH 442401 10PK SENS FNL-13S/ENT-4L
• 20874485000770: SHEATH 335601 10PK CHANNEL ENT-5000
• 20874485000756: SHEATH 035102 10PK 1.5MM TNE-5000
• 20874485000749: SHEATH 035101 10PK 2.1MM TNE-5000
• 00874485000769: SHEATH 225601 20PK SLIDE-ON ENT-5000