Duns Number:080458964
Device Description: Sterile Equipment Drape, Ultrasound probe, 8" X 55"
Catalog Number
781983
Brand Name
Spectrum, Inc.
Version/Model Number
982-03693-000
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
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
cba629c4-eee8-47cf-a426-29c1ccbb0872
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
00850301007211
Quantity per Package
10
Contains DI Package
00850301007204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| 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 |