AbClose M12
GUDID 04719872920328
The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision.
MEDEON BIODESIGN, INC.
Gastrointestinal endoscopic clip, long-term, non-bioabsorbable| Primary Device ID | 04719872920328 |
| NIH Device Record Key | 257dcf50-6ad7-4824-b6ec-a08a5ad59d94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AbClose |
| Version Model Number | M12 Rev.V24 |
| Catalog Number | M12 |
| Company DUNS | 656078460 |
| Company Name | MEDEON BIODESIGN, 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872920328 [Primary] |
| GS1 | 04719872920335 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 04719872920342 [Package] Contains: 04719872920335 Package: Carton [2 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-05 |
| Device Publish Date | 2021-04-27 |
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 | 2021-05-05The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision. |
| 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 |
Trademark Results [AbClose]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABCLOSE 88365649 not registered Live/Pending |
Medeon Biodesign, Inc. 2019-04-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.