AUTOCLAVABLE CAMERA HEAD

GUDID 04953170141775

"OTV-S7H-1NA VISERA AUTOCLAVABLE CAMERA H"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 04953170141775
• NIH Device Record Key: 1cf40480-529f-4b15-a7c3-211277a3cfb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOCLAVABLE CAMERA HEAD
• Version Model Number: OTV-S7H-1NA-10E
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170141775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955404

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170141775]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [AUTOCLAVABLE CAMERA HEAD]

• 04953170141898: "OTV-S7H-1NA-12E,VISERA AUTOCLA VABLE CAM"
• 04953170141867: "OTV-S7H-NA-12E,VISERA AUTOCLA VABLE CAME"
• 04953170141775: "OTV-S7H-1NA VISERA AUTOCLAVABLE CAMERA H"
• 04953170141836: OTV-S7H-1NA-10E
• 04953170141805: OTV-S7H-NA-10E
• 04953170141744: OTV-S7H-NA