Duns Number:025460908
Device Description: POUCH TYVEK 7.5X13 SELF STERRAD
Catalog Number
MPP100660SS
Brand Name
Medline
Version/Model Number
MPP100660SS
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
K123162,K123162,K123162
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
551ba035-24f0-454f-aec9-86222e153bb1
Public Version Date
December 31, 2020
Public Version Number
1
DI Record Publish Date
December 23, 2020
Package DI Number
30888277690077
Quantity per Package
200
Contains DI Package
10888277690073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |