FDA.reportPublic FDA data

Applier 30cm

Primary DI
M660AP030A0
Brand
Applier 30cm
Company
VIRTUAL PORTS LTD
Model
AP030A
Catalog number
AP030A
Published
2021-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GDOApplier, Surgical, Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M660AP030A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractor applierA non-sterile, hand-held, manually-operated surgical instrument designed to perform through a compatible endoscopic instrument (e.g., an access port) to insert, manipulate, and activate (apply) an internally-anchored endoscopic retractor to provide hands-free retraction of a selected internal organ. It typically consists of a pistol-like device with a long, thin, insertion portion and a distal tip that can interface a variety of devices; it also includes an interchangeable tubular sleeve for retractor insertion. The applier is also intended to extract the retractor after completion of the procedure. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
514870547
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M660EGS00A101EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EGS00A0EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EG000A101EndoGrabEG000AEG000A102024-03-01
M660EG000A0EndoGrabEG000AEG000A102024-03-01
M660EG000A102EndoGrabEG000AEG000A102021-06-23
M660EL000A52EndoLiftEL000AEL000A52021-06-23
M660AP045A0Applier 45cmAP045AAP045A2021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
G58690311220Novo SurgicalNOVO SURGICAL, INC.GDO2025-03-25
10381780544302CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2024-10-02
14026704738110WECKTELEFLEX INCORPORATEDGDO2024-07-17
14026704726384WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726391WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726407WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726414WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726421WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726438WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726445WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726452WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726469WECKTELEFLEX INCORPORATEDGDO2024-03-13