Duns Number:007941230
Device Description: Tray Laceration 2X2In 8Ply Gauze 4X4In 8Ply Gauze 18X26In Fenestrated Drape Kaycell Towel Tray Laceration 2X2In 8Ply Gauze 4X4In 8Ply Gauze 18X26In Fenestrated Drape Kaycell Towel Blue 19X27In Iris Scissor Straight 4.5In Adson Tissue Forcep 4.75In 1X2 Teeth Mosquito Halstead Curved 5In Webster Needle Holder Satin 5In Latex-Free Sterile Medicho
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
LAC1004
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
OVN
Product Code Name
Suture kit
Public Device Record Key
00eec8d4-d5c0-4e61-a52c-615eaf2f88fe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 20, 2016
Package DI Number
50885632114333
Quantity per Package
20
Contains DI Package
10885632114335
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 |