Inzii Ripstop Redeployable Retrieval System

GUDID 10607915145528

Redeployable tissue retrieval system with Ripstop nylon bag.

APPLIED MEDICAL RESOURCES CORPORATION

Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag
Primary Device ID10607915145528
NIH Device Record Key3fbef735-8bb7-48b3-bfad-9737071319d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameInzii Ripstop Redeployable Retrieval System
Version Model NumberCD005
Company DUNS187129135
Company NameAPPLIED MEDICAL RESOURCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter
Total Volume265 Milliliter
Lumen/Inner Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100607915145521 [Primary]
GS110607915145528 [Package]
Contains: 00607915145521
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-27
Device Publish Date2024-03-19

Devices Manufactured by APPLIED MEDICAL RESOURCES CORPORATION

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10607915145313 - GelPOINT V-Path 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System
10607915145320 - GelPOINT V-Path 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System
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