Duns Number:025460908
Device Description: DRAPE,67-1/2X112,STERI,XALT REIN,W-FEN
Catalog Number
MDTZ1017537AG
Brand Name
Medline
Version/Model Number
MDTZ1017537AG
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
-
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
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
08d6a1f2-cb73-4194-aefd-11af3ec3005e
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
20888277636573
Quantity per Package
12
Contains DI Package
10888277636576
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |