Duns Number:962532441
Device Description: CONTENTS:Endoscopy Kit- Lube Jelly (2)- Gauze (10)- Suction Tubing (10')- Cleaning Brush- CONTENTS:Endoscopy Kit- Lube Jelly (2)- Gauze (10)- Suction Tubing (10')- Cleaning Brush- Tote500ml BasinBiopsy Port CoverBiohazard StickerConcentrated Z-SpongeEndoscope Tip ProtectorValve Storage Bag
Catalog Number
ZUTR40001A
Brand Name
Zutron Medical
Version/Model Number
Endoscopy Procedure Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
dae1b554-1ee1-43d4-8223-2f3f8d443f4e
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
December 01, 2016
Package DI Number
00817658020010
Quantity per Package
25
Contains DI Package
00817658020003
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |