FDA.reportPublic FDA data

Applier 45cm

Primary DI
M660AP045AB0
Brand
Applier 45cm
Company
VIRTUAL PORTS LTD
Model
AP045A
Catalog number
AP045A
Device description
Reusable surgical instrument used to introduce and manipulate Virtual Ports' designated products.
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
M660AP045AB0PrimaryHIBCC0

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
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
514870547
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M660AP030AB0Applier 30cmAP030AAP030A2026-10-14
M660EGS00A101EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EGS00A0EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EG000A101EndoGrabEG000AEG000A102024-03-01
M660EG000A0EndoGrabEG000AEG000A102024-03-01
M660EG000A102EndoGrabEG000AEG000A102021-06-23
M660EL000A52EndoLiftEL000AEL000A52021-06-23
M660AP030A0Applier 30cmAP030AAP030A2021-06-23
M660AP045A0Applier 45cmAP045AAP045A2021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M660AP030AB0Applier 30cmVIRTUAL PORTS LTDGDO2026-10-14
14026704928702WECKTELEFLEX INCORPORATEDGDO2026-08-25
14026704928436WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928443WECKTELEFLEX INCORPORATEDGDO2026-08-21
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
14026704928559WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928566WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928573WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928580WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928597WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928603WECKTELEFLEX INCORPORATEDGDO2026-08-21
14026704928610WECKTELEFLEX INCORPORATEDGDO2026-08-21
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