Duns Number:007941230
Device Description: Tray Laceration 4X4 In 12-Ply Gauze 17X19IN Drape Blue Linen Operating Room Towel 18X26IN Tray Laceration 4X4 In 12-Ply Gauze 17X19IN Drape Blue Linen Operating Room Towel 18X26IN Fenestrated Operating Room Towel Iris Scissor Straight 4.5In Adson Tissue Forcep 4.75In 1X2 Teeth Adson Serrated Forcep 4.75In Mosquito Halstead Curved 5In Webster N
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
LAC1010
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)
-
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
ef35d024-b27e-453a-a9cd-090b7b5a0151
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 20, 2016
Package DI Number
50885632114340
Quantity per Package
20
Contains DI Package
10885632114342
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 |