Duns Number:177905486
Device Description: Disposable Bipolar Forceps 4" (10.2cm) Jewelers, Straight 0.4mm Tip and 12 ft. (3.6m) Cabl Disposable Bipolar Forceps 4" (10.2cm) Jewelers, Straight 0.4mm Tip and 12 ft. (3.6m) Cable
Catalog Number
-
Brand Name
Advanced Med-Surg Concepts
Version/Model Number
193-002
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
K900533,K900533,K900533
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
25e1eb2b-5d1e-42be-af49-eddc599db6e5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 10, 2016
Package DI Number
20841019110175
Quantity per Package
50
Contains DI Package
00841019110171
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-