DEVICE: ATEC (05420045503161)

Device Identifier (DI) Information

ATEC
ATEC TF-1
In Commercial Distribution
ATEC TF-1
Hologic, Inc.
05420045503161
GS1

1
018925968 *Terms of Use
No description.
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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
General tissue specimen container IVD, normal saline A covered plastic receptacle containing normal saline [0.9% w/v (weight per volume) sodium chloride] solution intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen for analysis and/or other investigation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KNW INSTRUMENT, BIOPSY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042290 000
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Sterilization

No
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: less than 15 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cde83c96-491d-4fac-9167-349a744cb355
July 06, 2018
3
September 03, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15420045503168 5 05420045503161 In Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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