AccessGUDID - DEVICE: Endo-Ease Lubricant (00867630000233)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Ease Lubricant
Version or Model: EEL-400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EEL-400
Company Name: SPIRUS MEDICAL LLC

Primary DI Number: 00867630000233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969696975 *Terms of Use

Device Description: A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMJ	Lubricant, Patient

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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