DEVICE: SOMATEX (08033860021771)

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Device Record History
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Device Identifier (DI) Information
SOMATEX
SOMACORE VERIFY S
Not in Commercial Distribution
900480-US
BIOPSYBELL SRL
08033860021771
GS1
April 28, 2025
1
438746708 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
16835 Soft-tissue biopsy procedure kit, non-medicated
A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FCG Biopsy Needle
KNW Instrument, Biopsy
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K130616 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
Length: 100 Millimeter
Needle Gauge: 14 Gauge
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Device Record Status
b289b74b-86e0-49fe-812a-711a42f1976a
April 29, 2025
5
August 01, 2016
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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
08033860021788 5 08033860021771 2025-04-28 Not 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
Yes
No CLOSE

Customer Contact

[?]
+39053527850
medical@biopsybell.it
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