TransEnterix X9007635

GUDID 74665329790176

Senhance Manipulator Drape 1-PK X9007635

DAS Medical International SRL

Patient surgical drape, single-use, sterile

• Primary Device ID: 74665329790176
• NIH Device Record Key: 0ea6e26d-f655-4c7b-985d-9d64e585b243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransEnterix
• Version Model Number: X9007635
• Catalog Number: X9007635
• Company DUNS: 817435655
• Company Name: DAS Medical International SRL
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx
• Phone: 809-556-8900
• Email: xx.xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	17466532979014 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	74665329790176 [Primary]

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

[74665329790176]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-11-30

On-Brand Devices [TransEnterix]

• 74665329790626: Senhance Articulating Drape X9007669
• 27466532979059: Senhance Articulating Drape X0007790
• 27466532979042: Sterile Tape for Robotic Drape X0008236
• 17466532979021: Senhance Manipulator Drape 3-PK X9007636
• 74665329790176: Senhance Manipulator Drape 1-PK X9007635
• 07466532979062: Senhance Articulating Drape X9007669
• 07466532979055: Senhance Articulating Drape X0007790
• 07466532979024: Senhance Manipulator Drape 3-PK X9007636
• 07466532979017: Senhance Manipulator Drape 1-PK X9007635