Duns Number:078573265
Device Description: 1.15 mm Zero-T punch
Catalog Number
119.115
Brand Name
1.15 mm Zero-T punch
Version/Model Number
IHTI-1.15-2S-094-V1 punch
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRY
Product Code Name
Punch, Surgical
Public Device Record Key
25782f0b-4445-41e7-a5b6-5df873f7bc9a
Public Version Date
February 12, 2021
Public Version Number
1
DI Record Publish Date
February 04, 2021
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 | 75 |