Duns Number:023055619
Device Description: SCANLAN® Pincap® orthopedic pin protectors - White, fits 3 pin/wire sizes: 0.71, 0.89, 1.1 SCANLAN® Pincap® orthopedic pin protectors - White, fits 3 pin/wire sizes: 0.71, 0.89, 1.14 mm, BNS (40 per bag)
Catalog Number
301-0110B
Brand Name
SCANLAN® Pincap® orthopedic pin protectors
Version/Model Number
301-0110B
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
KDC
Product Code Name
Instrument, Surgical, Disposable
Public Device Record Key
8f08cca5-838c-44d8-8f62-4404df280010
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 28, 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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |