Duns Number:007941230
Device Description: Suture Guide Curved 8 Numbered A And B Slots Single Patient Use, Sterile White Hdpe Base, Suture Guide Curved 8 Numbered A And B Slots Single Patient Use, Sterile White Hdpe Base, Blue Pvc Insert, White Foam Tape With High Tack Adhesive, White Paper Liner 3 Per Pack MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
SG0001
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"
Yes
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
GEJ
Product Code Name
CARRIER, LIGATURE
Public Device Record Key
b4683ed6-898b-4ec5-96d9-e13d6517ccc7
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
30885632065419
Quantity per Package
4
Contains DI Package
20885632065412
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |