FDA.report

Ponsky Endo-Sock

Primary DI
10816765010850
Brand
Ponsky Endo-Sock
Company
US Endoscopy
Model
00711042
Catalog number
00711042
Device description
Ponsky Endo-Sock Retrieval Pouch
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816765010850PackageGS15Not in Commercial Distribution
00816765010853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501085010816765010850
00816765010853008167650108538167650108530816765010853

GMDN Terms

TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an endoscopic procedure [e.g., endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)769-8226global@usendoscopy.com

Regulatory Flags

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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