Duns Number:014464314
Device Description: Bronchoscope Storage Cover 20x110cm with tape closure
Catalog Number
E6712
Brand Name
Exact Medical Manufacturing Inc
Version/Model Number
E6712
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
K101689,K101689,K101689
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
b7cc1687-60f0-481f-82b1-38c6d14e85fe
Public Version Date
April 29, 2020
Public Version Number
1
DI Record Publish Date
April 21, 2020
Package DI Number
00850015378447
Quantity per Package
160
Contains DI Package
00850015378430
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 489 |