Duns Number:969696975
Device Description: A water soluble and intended for medical purposes to lubricate body orifices to facilitat A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
Catalog Number
EEL-400
Brand Name
Endo-Ease Lubricant
Version/Model Number
EEL-400
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080042,K080042
Product Code
KMJ
Product Code Name
Lubricant, Patient
Public Device Record Key
a602804b-3367-4568-911c-c15d61ec464a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
40867630000200
Quantity per Package
4
Contains DI Package
00867630000233
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box