Identity
- Trade Name
- endoglide+™ FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Sterile Bacteriostatic Lubricating Gel FDA UDI
- Model / Reference
- SLT-394 FDA UDI
- Description
- Sterile Bacteriostatic Lubricating Gel FDA UDI
Identifiers
- Catalog Number
- SLT-394 FDA UDI
- Primary DI / UDI-DI
- 00840253115768 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- General-body orifice 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 32 Gram FDA UDI
Category: General-body orifice lubricant
endoglide+™ by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-body orifice lubricant.
- HR Lubricating Jelly — H R Pharmaceuticals, Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- NAR Kit — NORTH AMERICAN RESCUE, LLC.
- Dukal — Dukal LLC · Class I
- PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Sterile Bacteriostatic Lubricating Gel — Micro-tech Usa · Class I
- DynaLube, Sterile, 2.7 g Packet — Dynarex Corp. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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
- Boston Scientific
Sources (1)
- FDA UDI d4c6b188-6f13-493f-977f-203c35080698 35 fields · synced May 30, 2026