FDA UDI In Commercial Distribution 🇺🇸 United States

Compliance EndoKit™

DI: 00840253117410 · Model: CEK-792 · BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Compliance EndoKit™
Primary DI
00840253117410
Version / Model
CEK-792
Catalog Number
CEK-792
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-11-05
Public Version
3
Public Version Date
2019-10-23
Public Version Status
Update
Public Device Record Key
cb3fd607-e58c-4af7-8f60-66f7be4e4357

Device Description

Compliance EndoKit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Sterilization Prior Use
No

Product Codes

Code Name
MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

GMDN Terms

Code Name
45673 Endoscope cleaning kit
61950 Endoscopy preparation kit

Identifiers

Type ID
Package 00840253115355
Primary 00840253117410