DEVICE: Imbibe (07613327123616)

Device Identifier (DI) Information

Imbibe
2090-9047
In Commercial Distribution
2090-9047
Stryker Corporation
07613327123616
GS1

1
149183167 *Terms of Use
Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Body aspiration needle, single-use A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KNW INSTRUMENT, BIOPSY
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 20.0 Centimeter
Needle Gauge: 8.0 Gauge
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Device Record Status

b6cc2719-83f7-4385-b011-24253d37a2e1
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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

[?]
+1(610)640-1775
obxsharedservices@stryker.com
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