Echo PS Positioning System 5955000

GUDID 10801741077712

Echo PS Positioning System Inflation Assembly

Davol Inc.

Surgical mesh laparoscopic delivery/positioning device Surgical mesh laparoscopic delivery/positioning device

• Primary Device ID: 10801741077712
• NIH Device Record Key: de03353a-b5a8-49eb-b2fe-4ab2b3207f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo PS Positioning System
• Version Model Number: 5955000
• Catalog Number: 5955000
• Company DUNS: 001191048
• Company Name: Davol 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: true
• 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)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741077715 [Primary]
GS1	10801741077712 [Package]; Contains: 00801741077715; Package: CA [6 Units]; In Commercial Distribution

FDA Product Code

• OQL: Mesh, surgical, deployment balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-01-18

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• 00801741200762 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Left, 5” x 7”, 12 x 17 cm
• 00801741200779 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Medium, Right, 3" x 5", 8 x 13 cm
• 00801741200786 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm
• 00801741200793 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Right, 5” x 7”, 12 x 17 cm