eXact Suture Placement Device

GUDID 00854037007170

Cypris Medical, Inc.

Suturing unit, single-use

• Primary Device ID: 00854037007170
• NIH Device Record Key: d4f56871-497f-47ac-9eb5-3e51be486a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eXact Suture Placement Device
• Version Model Number: CM3061
• Company DUNS: 117322746
• Company Name: Cypris Medical, Inc.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854037007170 [Primary]

FDA Product Code

• GEJ: Carrier, Ligature

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: 2024-06-18
• Device Publish Date: 2024-06-10

Devices Manufactured by Cypris Medical, Inc.

• 00854037007170 - eXact Suture Placement Device: 2024-06-18
• 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: 2024-04-10 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