FDA UDI In Commercial Distribution 🇺🇸 United States

STERIS

DI: 00817688023531 · Model: SSESHR01 · I.C. MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
STERIS
Primary DI
00817688023531
Version / Model
SSESHR01
Catalog Number
SSESHR01
Company Name
I.C. MEDICAL, INC.
Labeler DUNS
616182895
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-19
Public Version
1
Public Version Date
2021-10-27
Public Version Status
New
Public Device Record Key
92580509-c19c-4b0a-9bba-78078d637dec

Device Description

ICM-000-0646 STERIS ESU Shroud, Short Tip & 9 Foot Tube, Sterile

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
46483 Surgical plume evacuation system tube

Identifiers

Type ID
Package 00817688023548
Primary 00817688023531

Customer Contacts

Phone
623-780-0700

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
0 – 140 Degrees Fahrenheit
Type
Storage Environment Humidity
Temperature Range
30 – 85 Percent (%) Relative Humidity