SLIDE-ON® ENDOSHEATH®

GUDID 20763000089621

SHEATH 224101 20PK OLYMPUS ENF-XP

MEDTRONIC XOMED, INC.

Optical medical device procedural cover

• Primary Device ID: 20763000089621
• NIH Device Record Key: 4d1be23e-36b0-43c8-931b-ef75689432cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLIDE-ON® ENDOSHEATH®
• Version Model Number: 224101
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00763000089627 [Primary]
GS1	20763000089621 [Package]; Contains: 00763000089627; Package: PK [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012543

FDA Product Code

• EOB: Nasopharyngoscope (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: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-07-07

On-Brand Devices [SLIDE-ON® ENDOSHEATH®]

• 20763000089737: SHEATH 226401 20PK STORZ RP1
• 20763000089720: SHEATH 226301 20PK STORZ 11101 RP
• 20763000089713: SHEATH 226101 20PK STORZ SK1
• 20763000089706: SHEATH 225601 20PK SLIDE-ON ENT-5000
• 20763000089690: SHEATH 225501 20PK PNTX VNL1170K/VNL1130
• 20763000089683: SHEATH 225401 20PK VSI ENT-2000/PNTX 10S
• 20763000089676: SHEATH 225301 20PK VSI EF100/MACH ENT3L
• 20763000089669: SHEATH 225101 20PK ENT 1000
• 20763000089652: SHEATH 224501 20PK OLYMPUS ENF-V
• 20763000089645: SHEATH 224401 20PK OLYMPUS P4
• 20763000089638: SHEATH 224301 20PK OLYMPUS P3/P2
• 20763000089621: SHEATH 224101 20PK OLYMPUS ENF-XP
• 20763000089614: SHEATH 222401 20PK PTX FNL13S/MACH ENT4L
• 20763000089607: SHEATH 222101 20PK MACHIDA ENT-2L
• 20763000038131: SHEATH 225601 20PK SLIDE-ON ENT-5000
• 20763000037981: SHEATH 226301 20PK STORZ 11101 RP
• 20763000037875: SHEATH 226401 20PK STORZ RP1
• 20763000037837: SHEATH 222101 20PK MACHIDA ENT-2L
• 20763000037974: SHEATH 226101 20PK STORZ SK1
• 20763000037967: SHEATH 225401 20PK VSI ENT-2000/PNTX 10S
• 20763000037950: SHEATH 225301 20PK VSI E-F100/MACH ENT3L
• 20763000037943: SHEATH 225101 20PK ENT 1000
• 20763000037936: SHEATH 224401 20PK OLYMPUS P4
• 20763000037929: SHEATH 224301 20PK OLYMPUS P3/P2
• 20763000037844: SHEATH 224101 20PK OLYMPUS ENF-XP
• 20763000037912: SHEATH 222401 20PK PTX FNL13S/MACH ENT4L
• 20763000037868: SHEATH 225501 20PK PNTX VNL1170K/VNL1130