FDA.reportPublic FDA data

AbGrab

Primary DI
00860003326411
Brand
AbGrab
Company
Lapovations, LLC
Model
AG1-001
Device description
Laparoscopic Lifting Device
Published
2021-08-19
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

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
20860003326415PrimaryGS10
00860003326411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000332641520860003326415
00860003326411008600033264118600033264110860003326411

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.

Sterilization Methods#

Method table
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860003326401AbGrabAG2-2032025-07-25
20860003326408AbGrabAG2-2042025-07-25
00860003326404AbGrabAG2-2042025-07-25
00860003326435AbGrabAG2-2022022-10-31
10860003326425AbGrabAG2-2012022-10-31
20860003326415AbGrabAG1-0012021-08-19
10860003326418AbGrabAG1-0012021-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421601MillenniumAvalign Technologies, Inc.NWV2026-05-05
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00848657078368AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-04-23
00190776420277MillenniumAvalign Technologies, Inc.NWV2026-04-16
00190776418991MillenniumAvalign Technologies, Inc.NWV2026-04-13
00190776418427MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418434MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418441MillenniumAvalign Technologies, Inc.NWV2026-03-25
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05
00190776414344MillenniumAvalign Technologies, Inc.NWV2025-10-23
00190776413910MillenniumAvalign Technologies, Inc.NWV2025-10-21
00190776413958MillenniumAvalign Technologies, Inc.NWV2025-10-21
00848657077682AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15