FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 10724995003439 · Model: Quick Connect · STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
10724995003439
Version / Model
Quick Connect
Catalog Number
QKC2005
Company Name
STERIS CORPORATION
Labeler DUNS
868205779
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-04
Public Version
8
Public Version Date
2023-10-31
Public Version Status
Update
Public Device Record Key
00f298c3-a820-49b2-a0c2-743d37824b91

Device Description

The Quick Connect for Karl Storz and Richard Wolf Flexible Endoscopes are used with C1160E Universal Flexible Processing Trays in the SYSTEM 1 endo Liquid Chemical Processing System.

Device Characteristics

Single Use
No
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MED Sterilant, medical devices

GMDN Terms

Code Name
61723 Luminal device flushing tubing set, reusable

Identifiers

Type ID
Primary 10724995003439

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K173256 000
K182827 000
K190104 000
K191343 000
K192929 000
K210737 000
K211607 000
K222615 000
K232914 000