Duns Number:942377524
Device Description: Integra® External Fixation SystemThe punch is used for the half pin drill guide in the ext Integra® External Fixation SystemThe punch is used for the half pin drill guide in the external fixation system.
Catalog Number
12225020002
Brand Name
Integra®
Version/Model Number
12225020002
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
ea23e8d1-dc2a-487c-8d42-cdf41262797e
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
August 30, 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 | 1909 |
2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
3 | A medical device with high risk that requires premarket approval | 12 |
U | Unclassified | 15 |