Synvisc One

GUDID 00864223000229

EAGLE SPRINGS ENTERPRISES LLC

Synovial fluid supplementation medium

• Primary Device ID: 00864223000229
• NIH Device Record Key: 2edd0af4-2734-42ff-9546-7680f4a4992c
• Commercial Distribution Discontinuation: 2018-03-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Synvisc One
• Version Model Number: Hylan GF-20
• Company DUNS: 080088337
• Company Name: EAGLE SPRINGS ENTERPRISES LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864223000229 [Primary]

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

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: 2016-03-14

Devices Manufactured by EAGLE SPRINGS ENTERPRISES LLC

• 00864223000205 - Euflexxa: 2018-03-29
• 00864223000212 - Synvisc: 2018-03-29
• 00864223000229 - Synvisc One: 2018-03-29
• 00864223000229 - Synvisc One: 2018-03-29
• 00864223000236 - Orthovisc: 2018-03-29
• 00866394000206 - Hyalgan: 2018-03-29
• 00866394000213 - Supartz: 2018-03-29