AbClose

Primary DI
04719872920328
Brand
AbClose
Company
MEDEON BIODESIGN, INC.
Model
M12 Rev.V24
Catalog number
M12
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.
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HCFInstrument, Ligature Passing And Knot Tying
OCWEndoscopic Tissue Approximation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872920335PackageGS15In Commercial Distribution
04719872920342PackageGS12In Commercial Distribution
04719872920328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872920335047198729203354719872920335
04719872920342047198729203424719872920342
04719872920328047198729203284719872920328

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, long-term, non-bioabsorbableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656078460
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872920359Cross-Seal0020022022-02-01
04719872920380Cross-Seal0020022022-02-01
04719872920014MedeonM12M122017-01-16
04719872920274ClickClean™ S330-SPS330-SP2020-05-15
04719872920281ClickClean™ S330-SPS330-SP2020-05-15
04719872920151ClickClean™ UL030UL0302019-05-03
04719872920182ClickClean™ UL330UL3302019-05-03
04719872920243ClickClean™ US030-SOUS030-SO2020-03-04
04719872920250ClickClean™ US030-SOUS030-SO2020-03-04
04719872920038ClickClean™ L0322017-07-31
04719872920090ClickClean™ UL030UL0302018-11-20
04719872920120ClickClean™ UL330UL3302018-12-24
04719872920045ClickClean™ L0322017-07-31
04719872920113ClickClean™ UL030UL0302018-11-20
04719872920144ClickClean™ UL330UL3302018-12-24

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