Duns Number:080458964
Device Description: Sterile Equipment Drape, Tear Tip, 7"X96"
Catalog Number
706931
Brand Name
Spectrum, Inc.
Version/Model Number
982-03567-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K934630,K934630,K934630
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
0c455d59-290f-4ab3-b96b-31655d311d16
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 30, 2017
Package DI Number
00850301007044
Quantity per Package
25
Contains DI Package
00850301007037
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 11 |