FDA UDI In Commercial Distribution 🇺🇸 United States

SteriTec 4/10 Load Challenge Test Pack

DI: 00814434020240 · Model: LT 111 · STERITEC PRODUCT MFG. CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SteriTec 4/10 Load Challenge Test Pack
Primary DI
00814434020240
Version / Model
LT 111
Catalog Number
LT 111
Company Name
STERITEC PRODUCT MFG. CO., INC.
Labeler DUNS
622223196
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
3
Public Version Date
2021-02-19
Public Version Status
Update
Public Device Record Key
81c6f58e-9499-4cc0-bbfd-0a189a28c288

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
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
No
Sterilization Prior Use
No

Product Codes

Code Name
JOJ Indicator, Physical/Chemical Sterilization Process

GMDN Terms

Code Name
35362 Chemical/physical sterilization process indicator

Identifiers

Type ID
Package 10814434020247
Primary 00814434020240

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
10 – 38 Degrees Celsius
Type
Storage Environment Humidity
Temperature Range
10 – 60 Percent (%) Relative Humidity