Medeon M12

GUDID 04719872920014

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is use

MEDEON BIODESIGN, INC.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 04719872920014
• NIH Device Record Key: 44d30ff0-bf6c-4327-899f-01dab4d970e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medeon
• Version Model Number: M12
• Catalog Number: M12
• Company DUNS: 656078460
• Company Name: MEDEON BIODESIGN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872920014 [Primary]
GS1	04719872920021 [Package]; Package: Carton [12 Units]; In Commercial Distribution
GS1	04719872920076 [Package]; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• HCF: Instrument, Ligature Passing And Knot Tying

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-01-16

Devices Manufactured by MEDEON BIODESIGN, INC.

• 04719872920359 - Cross-Seal: 2022-02-09 The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle. The Cross-Seal Device tracks over a standar
• 04719872920380 - Cross-Seal: 2022-02-09 The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the
• 04719872920328 - AbClose: 2021-05-05 The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide Th
• 04719872920281 - ClickClean™: 2020-05-25 The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath tha
• 04719872920090 - ClickClean™: 2020-05-07 The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath tha
• 04719872920120 - ClickClean™: 2020-05-07 The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath tha
• 04719872920250 - ClickClean™: 2020-03-12 The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath tha
• 04719872920045 - ClickClean™: 2019-04-09 The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath tha