Duns Number:072656713
Device Description: The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains:A 5.5" Straight Crile HemostatA 4.5" Straight Iris ScissorsA 9.75" Medium Magill ForcepsA 6" Mayo-Hegar needle driver, andA protective sterile field wrap
Catalog Number
HHSIT01
Brand Name
H&H Situation Instrument Tray Kit
Version/Model Number
1
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
ffa1de0b-6aad-4871-bd62-446d197224e1
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
July 06, 2020
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |