FDA.reportPublic FDA data

AbGrab

Primary DI
10860003326401
Brand
AbGrab
Company
Lapovations, LLC
Model
AG2-203
Device description
Gen 2 AbGrab Ebeam Sterilized Kit
Published
2025-07-25
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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860003326401PrimaryGS10
00860003326404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000332640110860003326401
00860003326404008600033264048600033264040860003326404

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access suction domeA sterile dome-shaped device intended to facilitate laparoscopic-insufflation needle insertion by causing the anterior abdominal wall to separate from the underlying viscera using vacuum applied to the surface of the abdomen, thereby creating a space for the needle tip. It is typically made of synthetic polymer materials and is designed to be used with the hospital central vacuum system. This is a single-use device.

Regulatory Flags#

DUNS number
081051875
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860003326408AbGrabAG2-2042025-07-25
00860003326404AbGrabAG2-2042025-07-25
00860003326435AbGrabAG2-2022022-10-31
10860003326425AbGrabAG2-2012022-10-31
20860003326415AbGrabAG1-0012021-08-19
10860003326418AbGrabAG1-0012021-08-19
00860003326411AbGrabAG1-0012021-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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