Duns Number:006999858
Device Description: Circumcision Drape, 55% cotton/45% polyester 1 Ply Standard Supreme, 1 ply Barrier Supreme Circumcision Drape, 55% cotton/45% polyester 1 Ply Standard Supreme, 1 ply Barrier Supreme Reinforcement pad on back of drape, w 1" round fenestration, concealed hems around fenestration and reinforcement, hemmed all around, 12x12
Catalog Number
96201672
Brand Name
Fenestrated Circumcision Drape
Version/Model Number
96201672
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
-
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
468f143e-5382-46b2-886e-8759eedd0a2d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |