Duns Number:007941230
Device Description: Pouch Sterilization Heat-Seal Ethylene Oxide Steam Dual Indicator Blue-Tinted Kraft Paper Pouch Sterilization Heat-Seal Ethylene Oxide Steam Dual Indicator Blue-Tinted Kraft Paper 100 Feet 3 Inch Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
HR3100
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
503b0320-c621-41e5-9e1e-546fe660078b
Public Version Date
September 05, 2022
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632101548
Quantity per Package
8
Contains DI Package
10885632101540
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |