DEVICE: BTT (08033959221730)

Device Identifier (DI) Information

BTT
BTT
In Commercial Distribution
BTT1109
STERYLAB SRL
08033959221730
GS1

1
439659574 *Terms of Use
bone-marrow trasplantation needle 11G 9 cm
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16833 Bone marrow biopsy procedure kit
A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNW Instrument, Biopsy
FCG Biopsy Needle
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051506 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

52d3ff09-ff17-4780-a60a-c5007b4bc0b5
October 10, 2019
1
October 02, 2019
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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
18033959221737 5 08033959221730 In Commercial Distribution
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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)

[?]
No
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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