Duns Number:008124539
Device Description: Minor Laceration Tray with Instruments: Plastic Tray, 5 Gauze Sponges, Waterproof Blue Dra Minor Laceration Tray with Instruments: Plastic Tray, 5 Gauze Sponges, Waterproof Blue Drape, Fenestrated Waterproof Drape, 2 Absorbent Towels, Tissues Forceps, Needle Holder, Scissors
Catalog Number
-
Brand Name
Minor Laceration Tray with Instruments
Version/Model Number
4523
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
df98a833-e777-47b2-b784-1d7a3db9b9aa
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
June 21, 2021
Package DI Number
00616784452333
Quantity per Package
20
Contains DI Package
00616784452326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |