FDA.report

AbGrab

Primary DI
00860003326435
Brand
AbGrab
Company
Lapovations, LLC
Model
AG2-202
Device description
AbGrab Gen 2 Laparoscopic Lifting Device - Master Box Kit
Published
2022-10-31
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860003326435PrimaryGS10
00860003326428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003326435008600033264358600033264350860003326435
00860003326428008600033264288600033264280860003326428

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081051875
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860003326404AbGrabAG2-2042025-07-25
10860003326425AbGrabAG2-2012022-10-31
10860003326418AbGrabAG1-0012021-08-19
00860003326411AbGrabAG1-0012021-08-19

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