Imbibe 2090-9029

GUDID 07613327123562

Bone Marrow Aspiration Needle

Stryker Corporation

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• Primary Device ID: 07613327123562
• NIH Device Record Key: fe3d25b7-ea68-4a94-abd5-402c4660a66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imbibe
• Version Model Number: 2090-9029
• Catalog Number: 2090-9029
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com
• Phone: +1(610)640-1775
• Email: obxsharedservices@stryker.com

Device Dimensions

• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge
• Length: 15 Centimeter
• Needle Gauge: 8 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153306

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Imbibe]

• 00808232000788: Bone Marrow Aspiration Syringe
• 00808232000771: Bone Marrow Aspiration Syringe
• 00808232000764: Bone Marrow Aspiration Syringe
• 07613327123623: Beveled Bone Marrow Aspiration Needle, Bullet Tip Stylet, Stylet
• 07613327123616: Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet
• 07613327123609: Fenestrated Beveled Bone Marrow Aspiration Needle, Bullet Tip Stylet, Stylet
• 07613327123593: Beveled Bone Marrow Aspiration Needle, Bulltet Tip Stylet, Stylet
• 07613327123586: Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet
• 07613327123579: Fenestrated Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet
• 07613327123562: Bone Marrow Aspiration Needle
• 07613327123555: Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet