Duns Number:190572854
Device Description: CHIA PERCPASSER Suture Passer and Instruments 1.6mm x 35cm (14 Inches) Guidewire, 1.1mm x CHIA PERCPASSER Suture Passer and Instruments 1.6mm x 35cm (14 Inches) Guidewire, 1.1mm x 35cm (14 Inches) Guidewire, 1.1mm x 38cm (15 Inches) Nitinol Guidewire, 2.4mm x 38cm (15 Inches) Trocar Tip Calibrated Pin ( Percent accuracy = Plus or Minus 5 Percent), CHIA PERCPASSER Suture Passer, Marking Pen, Ruler ( Percent accuracy = Plus or Minus 1 Percent).
Catalog Number
232459
Brand Name
CHIA PERCPASSER
Version/Model Number
232459
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
Yes
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
304c95f4-ec53-4ec4-8301-fd5a18f9e6f1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2015
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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |