Duns Number:316116623
Device Description: HybridKnife® T-Type I-Jet OD 2.3mm; L 1.9m
Catalog Number
20150-260
Brand Name
ERBE
Version/Model Number
20150-260
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
K083608,K083608
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
6cd28c74-0290-45be-a3e2-dd039a24d757
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
04050147018341
Quantity per Package
5
Contains DI Package
04050147018334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Level: 1
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 154 |