Duns Number:002348191
Device Description: 12 FOOT DISPOSABLE BIPOLAR FORCEPS CORD (10/BOX)
Catalog Number
394236
Brand Name
PILLING
Version/Model Number
IPN039268
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
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
K823755,K823755,K823755,K823755
Product Code
HAM
Product Code Name
APPARATUS, ELECTROSURGICAL
Public Device Record Key
d6b2926b-0091-4f11-b392-bea900830cdd
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
June 03, 2019
Package DI Number
34026704662112
Quantity per Package
13
Contains DI Package
24026704662115
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |