FDA UDI In Commercial Distribution 🇺🇸 United States

endoglide+™

DI: 00840253115768 · Model: SLT-394 · BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
endoglide+™
Primary DI
00840253115768
Version / Model
SLT-394
Catalog Number
SLT-394
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-31
Public Version
3
Public Version Date
2023-02-01
Public Version Status
Update
Public Device Record Key
d4c6b188-6f13-493f-977f-203c35080698

Device Description

Sterile Bacteriostatic Lubricating Gel

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KMJ Lubricant, patient

GMDN Terms

Code Name
60796 General-body orifice lubricant

Identifiers

Type ID
Package 00816849016870
Primary 00840253115768
Package 00816849017167

Device Sizes

Type Value Unit Text
Weight 32 Gram