Duns Number:962768169
Device Description: Paddle Shaver Instrument
Catalog Number
2100T-1608
Brand Name
Alamo P, Alamo T
Version/Model Number
2100T-1608
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120401,K122047,K140303
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
b9e710a4-e375-4bc9-961d-0bce3fd839b4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 01, 2017
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 | 247 |
2 | A medical device with a moderate to high risk that requires special controls. | 291 |