DEVICE: PressTo (08056138586390)

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Device Record History
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Device Identifier (DI) Information
PressTo
PS0810
In Commercial Distribution
PS0810
M.D.L. S.R.L.
08056138586390
GS1

1
447228586 *Terms of Use
DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH INTERNAL TRAP SYSTEM, SAFETY, WIRE 8G x 100 mm
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Device Characteristics
MR Unsafe
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?
46350 Bone marrow biopsy needle, single-use
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWO Needle, Biopsy, Cardiovascular
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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: 8 Gauge
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Device Record Status
bd78b43f-d41b-4258-934b-3a478ebf39d5
May 27, 2021
2
May 17, 2021
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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
18056138586397 10 08056138586390 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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