DEVICE: BTT (08033959222287)

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Device Record History
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Device Identifier (DI) Information
BTT
BTT
In Commercial Distribution
BTT1307
STERYLAB SRL
08033959222287
GS1

1
439659574 *Terms of Use
bone-marrow trasplantation needle 13G 7 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
01e4355e-fbf3-42d5-a1e8-2394f880291b
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
No Package DIs found
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Secondary DI

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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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