Duns Number:002418234
Device Description: Incision & Drainage Instrument Tray with Safety Scalpel
Catalog Number
558
Brand Name
Busse Hospital Disposables
Version/Model Number
558
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
2cd40be0-27c5-4123-ab41-09a616548af1
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 07, 2020
Package DI Number
10849233010908
Quantity per Package
20
Contains DI Package
00849233010901
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 298 |