Duns Number:012430880
Device Description: OR Towels 17x27 Blue 100% Cotton Pouch Latex Free
Catalog Number
5701114
Brand Name
Henry Schein
Version/Model Number
5701114
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
-
Product Code
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
c8144c08-c4e6-4265-8846-c012a4a7c180
Public Version Date
March 03, 2020
Public Version Number
1
DI Record Publish Date
February 24, 2020
Package DI Number
10304040091125
Quantity per Package
12
Contains DI Package
00304040091128
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |