DEVICE: Henry Schein (00304040006009)
Device Identifier (DI) Information
Henry Schein
1012226
In Commercial Distribution
1012226
HENRY SCHEIN, INC.
1012226
In Commercial Distribution
1012226
HENRY SCHEIN, INC.
Sterilization Tubing Cont Clr
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Sterilization packaging, single-use | A device intended to be used to enclose medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRG | Wrap, sterilization |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K870147 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Width: 4 Inch |
Device Record Status
82665972-4ec0-4eeb-a83b-bb7b3bd7a3c5
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10304040006006 | 12 | 00304040006009 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined