C SAFE

GUDID 20888937020124

C SAFE Safety Scalpel

Coopersurgical, Inc.

Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use Scalpel, single-use

• Primary Device ID: 20888937020124
• NIH Device Record Key: 038af94e-c92c-4538-a8c4-978971c33486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C SAFE
• Version Model Number: BX101
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888937020127 [Unit of Use]
GS1	20888937020124 [Primary]

FDA Product Code

• GDX: Scalpel, One-Piece

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: 2024-02-01
• Device Publish Date: 2024-01-24

Devices Manufactured by Coopersurgical, Inc.

• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023824 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023831 - K-Systems: 2024-02-27 L126 IVF, RI Witness Right