Duns Number:080361159
Device Description: PILL CRUSHER POUCHES, RIBBED, BEVELED SEAM, TIGER PATENT, 50/BAG
Catalog Number
-
Brand Name
TIGER MEDICAL
Version/Model Number
PPT003
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
OHY
Product Code Name
Pill Crusher/Cutter
Public Device Record Key
49ee99a5-b534-4697-a162-0c3d2085118d
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 31, 2022
Package DI Number
10840216100111
Quantity per Package
8000
Contains DI Package
00840216100114
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |