Duns Number:878070325
Device Description: Endoscopy ORE Kit; Each Kit Includes Draw String Tote, 32 oz Bowl, 16 oz Bowl, 4x4 Gauze P Endoscopy ORE Kit; Each Kit Includes Draw String Tote, 32 oz Bowl, 16 oz Bowl, 4x4 Gauze PRM (20), 1.4 oz Lube Jelly, 1/4x120 in TBG Suction (2), 30cc Syringe, Connector TBG Straight (2), Biopsy Valve Sterile, 60ML Syringe, Sponge Cleaning Endozime SLR, 2g Enzymatic in Water Label, Dirty Scope Label, and Sterile Water Label.
Catalog Number
10-6010ORE
Brand Name
Bosma Enterprises
Version/Model Number
10-6010ORE
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PWU
Product Code Name
Clean-Up Kit
Public Device Record Key
7d6a8156-b1f8-44a7-9399-d95afd041077
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020854
Quantity per Package
16
Contains DI Package
00818634020857
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |