DEVICE: Henry Schein (00304040022412)

Device Identifier (DI) Information

Henry Schein
5700312
In Commercial Distribution
5700312
HENRY SCHEIN, INC.
00304040022412
GS1

1
012430880 *Terms of Use
Steam BI Test Pack
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Biological sterilization indicator A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FRC Indicator, biological sterilization process
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: controlled room temperature
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Area/Surface Area: 29 Square inch
CLOSE

Device Record Status

780a2740-6719-468a-b66a-e57d5761d944
March 29, 2018
2
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10304040022419 25 00304040022412 In Commercial Distribution box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE