FDA.report

The Advantage Polyp Trap-Quad Chamber Polyp Trap

Primary DI
30677964054946
Brand
The Advantage Polyp Trap-Quad Chamber Polyp Trap
Company
MEDIVATORS INC.
Model
100104
Published
2021-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30677964054946PackageGS150In Commercial Distribution
00677964054945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796405494630677964054946
00677964054945006779640549456779640549450677964054945

GMDN Terms

TermDefinition
Gastrointestinal/airway foreign body retrieval basket, single-useA flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873custserv@medivators.com

Regulatory Flags

DUNS number
068199363
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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50677964153056Endo Carry-on Procedure Kit401104140110412026-03-12
50677964153063Endo Carry-on Procedure Kit401104240110422026-03-12

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