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
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
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14026704928450WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928467WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928474WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928481WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928498WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928504WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928511WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928528WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928535WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928542WECKTELEFLEX INCORPORATEDGDO2026-08-21
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14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928603WECKTELEFLEX INCORPORATEDGDO2026-08-21
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14026704928627WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928634WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928641WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928658WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928665WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928672WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928689WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928696WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928719WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928726WECKTELEFLEX INCORPORATEDGDO2026-08-21