Duns Number:878070325
Device Description: Accelerate-OR Lithotomy CIL Kit; Each Kit Includes 40x60 Sahara OR Table Sheet 20" Absorb Accelerate-OR Lithotomy CIL Kit; Each Kit Includes 40x60 Sahara OR Table Sheet 20" Absorb (2), and 20x29 Disposable Pillowcase.
Catalog Number
10-8020CIL
Brand Name
Bosma Enterprises
Version/Model Number
10-8020CIL
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
30c86b01-6d0f-437e-8da9-4f58140882ca
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
July 02, 2021
Package DI Number
10818634020717
Quantity per Package
16
Contains DI Package
00818634020710
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 |