eXact Suture 4-0 PDO

GUDID 00854037007101

eXact Suture, 4-0 PDO

Cypris Medical, Inc.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00854037007101
• NIH Device Record Key: 07c37e7e-41b2-42c3-994a-6ed4b3c59fc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eXact Suture 4-0 PDO
• Version Model Number: CM7440
• Company DUNS: 117322746
• Company Name: Cypris Medical, 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: true
• 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	00854037007101 [Primary]

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-10
• Device Publish Date: 2024-04-02

Devices Manufactured by Cypris Medical, Inc.

• 00854037007170 - eXact Suture Placement Device: 2024-06-18
• 00854037007026 - eXact Suture 4-0 PP: 2024-04-10 eXact Suture, 4-0 Polypropylene
• 00854037007040 - eXact Suture 3-0 PP: 2024-04-10 eXact Suture, 3-0 Polypropylene
• 00854037007064 - eXact Suture 2-0 PTFE: 2024-04-10 eXact Suture, 2-0 PTFE
• 00854037007088 - eXact Suture 3-0 PTFE: 2024-04-10 eXact Suture, 3-0 PTFE
• 00854037007101 - eXact Suture 4-0 PDO: 2024-04-10eXact Suture, 4-0 PDO
• 00854037007101 - eXact Suture 4-0 PDO: 2024-04-10 eXact Suture, 4-0 PDO
• 00854037007125 - eXact Suture 3-0 PDO: 2024-04-10 eXact Suture, 3-0 PDO
• 00854037007149 - eXact 5.1: 2023-03-08