Duns Number:015272206
Device Description: Bipolar forceps sterilization tray, 11 1/4'' W x 12'' L x 1 1/2'' H, base, lid, and bars, Bipolar forceps sterilization tray, 11 1/4'' W x 12'' L x 1 1/2'' H, base, lid, and bars, accommodates 10 forceps
Catalog Number
93-129
Brand Name
Ambler Surgical
Version/Model Number
Bipolar forceps sterilization tray
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"
-
For Single-Use
-
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
ca21008c-b8b4-4fb8-b9bf-81d0553d049c
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
January 04, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |