Duns Number:021717889
Device Description: Integrated Biopsy Cap and Guidewire Locking Device
Catalog Number
4513
Brand Name
AutoCap™ RX
Version/Model Number
M00545130
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ODC
Product Code Name
Endoscope channel accessory
Public Device Record Key
8754be0e-c2e8-4c8a-8de6-c0d6181709f6
Public Version Date
July 02, 2021
Public Version Number
1
DI Record Publish Date
June 24, 2021
Package DI Number
00191506000745
Quantity per Package
10
Contains DI Package
00191506000752
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |