Identity
- Trade Name
- Endo-Ease Lubricant FDA UDI
- Generic Name
- Vaginal lubricant FDA UDI
- Device Name
- A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. FDA UDI
- Model / Reference
- EEL-400 FDA UDI
- Description
- A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. FDA UDI
Identifiers
- Catalog Number
- EEL-400 FDA UDI
- Primary DI / UDI-DI
- 00867630000233 FDA UDI
- 510(k) Number
- K080042 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- Vaginal lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal lubricant
Endo-Ease Lubricant by Spirus Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal lubricant.
- Careone — Ahold U.S.A., Inc. · Class II
- Breeze by Rexall — DOLGENCORP, LLC · Class II
- Durex Cheeky Play Silicone Long Lasting Pleasure/Durex Cheeky Play Silicone — RB Health (us) LLC · Class II
- DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana — RB Health (us) LLC · Class II
- Conceive Plus — Sasmar Pharmaceuticals SPRL · Class II
- KY Love Passion Couples Lubricant — RB Health (us) LLC · Class II
- Aloe Cadabra — Live Well Brands, INC. · Class II
- 2.5 oz Silky Moisture Personal Lubricant — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spirus Medical, LLC
Sources (1)
- FDA UDI a602804b-3367-4568-911c-c15d61ec464a 36 fields · synced May 30, 2026