AccessGUDID - DEVICE: AbClose (04719872920328)

GUDID

Device Identifier (DI) Information

Brand Name: AbClose
Version or Model: M12 Rev.V24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M12
Company Name: MEDEON BIODESIGN, INC.

Primary DI Number: 04719872920328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656078460 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HCF	Instrument, Ligature Passing And Knot Tying
GCJ	Laparoscope, General & Plastic Surgery
OCW	Endoscopic Tissue Approximation Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 257dcf50-6ad7-4824-b6ec-a08a5ad59d94
Public Version Date: May 05, 2021
Public Version Number: 1
DI Record Publish Date: April 27, 2021