PIPELINE 288226070

GUDID 10705034221045

PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 70mm

DEPUY SPINE, LLC

Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use Surgical retractor/retraction system blade, single-use

• Primary Device ID: 10705034221045
• NIH Device Record Key: 37037a16-af61-4dd8-8486-f974939b8783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIPELINE
• Version Model Number: 288226070
• Catalog Number: 288226070
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034221045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992898

FDA Product Code

• GZT: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-06-30

On-Brand Devices [PIPELINE]

• 10705034221106: PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 80mm
• 10705034221090: PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 70mm
• 10705034221083: PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 60mm
• 10705034221076: PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 50mm
• 10705034221069: PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 40mm
• 10705034221052: PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 80mm
• 10705034221045: PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 70mm
• 10705034221038: PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 60mm
• 10705034221021: PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 50mm
• 10705034221014: PIPELINE ACCESS SYSTEM RETRACTION PORT 26 x 40mm
• 10705034220765: PIPELINE ACCESS SYSTEM BLADE REMOVER
• 10705034220741: PIPELINE ACCESS SYSTEM DISTRACTOR
• 10705034217741: PIPELINE LS ACCESS SYSTEM BLADE ADJUSTOR
• 10705034220512: PIPELINE ACCESS SYSTEM DOWN BITING CURETTE, OFFSET 6mm
• 10705034220505: PIPELINE ACCESS SYSTEM DOWN-BITING CURETTE, STRAIGHT 6mm
• 10705034220499: PIPELINE ACCESS SYSTEM RING CURETTE, STRAIGHT 6.5mm
• 10705034220482: PIPELINE ACCESS SYSTEM RING CURETTE, ANGLE 6.5mm
• 10705034220475: PIPELINE ACCESS SYSTEM CURETTE, LEFT ANGLE 6.5mm
• 10705034220468: PIPELINE ACCESS SYSTEM CURETTE, RIGHT ANGLE 6.5mm
• 10705034220451: PIPELINE ACCESS SYSTEM STRAIGHT CURETTE WITH TEETH 6.5mm
• 10705034220444: PIPELINE ACCESS SYSTEM STRAIGHT CURETTE 6.5mm
• 10705034220734: PIPELINE access system Fiberoptic light guides
• 10705034217789: PIPELINE LS Lateral access system Light cable
• 10705034217727: PIPELINE LS Lateral access system Light source
• 10705034217604: PIPELINE LS ACCESS SYSTEM DILATOR HOLDER
• 10705034220918: PIPELINE ACCESS SYSTEM TOP TRAY
• 10705034220901: PIPELINE ACCESS SYSTEM CASE AND TRAY
• 10705034220895: PIPELINE ACCESS SYSTEM CASE AND TRAY
• 10705034220574: PIPELINE ACCESS SYSTEM INTERBODY CASE AND TRAY
• 10705034220567: PIPELINE ACCESS SYSTEM DISCECTOMY CASE AND TRAY
• 10705034218137: PIPELINE LS ACCESS SYSTEM LATERAL ACCESS CASE AND TRAY
• 10705034359953: PIPELINE LS ACCESS SYSTEM TELESCOPING BLADE
• 10705034221007: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 85mm
• 10705034220994: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 65mm
• 10705034220987: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 45mm
• 10705034220970: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 85mm
• 10705034220963: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 65mm
• 10705034220956: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 45mm
• 10705034220949: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, SMALL 85mm
• 10705034220932: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, SMALL 65mm
• 10705034220925: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, SMALL 45mm
• 10705034220888: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 95mm
• 10705034220871: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 75mm
• 10705034220864: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 55mm
• 10705034220857: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, LARGE 35mm
• 10705034220840: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 95mm
• 10705034220833: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 75mm
• 10705034220826: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 55mm
• 10705034220819: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, MEDIUM 35mm
• 10705034220802: PIPELINE ACCESS SYSTEM MEDIAL LATERAL BLADE, SMALL 95mm