MAYFIELD®

GUDID M268439A10531

XR2 RETAINING RING

INTEGRA LIFESCIENCES CORPORATION

Skull clamp

• Primary Device ID: M268439A10531
• NIH Device Record Key: c10abb76-49e2-4284-99e1-d9ab18611bb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAYFIELD®
• Version Model Number: 439A1053
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780256250 [Primary]
HIBCC	M268439A10531 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090506

FDA Product Code

• HBL: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-08-02

On-Brand Devices [MAYFIELD®]

• M268SGS5601: O-RING 1/16 X 3/16" X 5/16"
• M268SGS3191: FOAM PAD
• M268SGS3181: PLASTIC BOX
• M268S41A14361: DISPOSABLE PIN BOX
• M268SGS9181: 20 PITCH SPUR GEAR
• M268GS9181: 20 PITCH SPUR GEAR
• M268GS5601: O-RING 1/16 X 3/16" X 5/16"
• M268GS3191: FOAM PAD
• M268GS3181: PLASTIC BOX
• M26841A14361: DISPOSABLE PIN BOX
• M268A11221: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A11211: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A11201: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A11191: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A10841: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A10831: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A10721: The MAYFIELD® Skull Pins are intended for use with a skull clamp that is placed on the patientâ
• M268A20211: MAYFIELD MR SKULL PIN STARTER KIT (E8806FA)
• M268SGS1171: O-RING 3/16" X 5/16" X 1/16"
• M268S431A31141: Case Label, Infinity XR2 Skull Clamp (REF A2114) (Polycarbonate)
• M268S431A10851: Label "A-2002" (Polyester)
• M268S421A11231: MAYFIELD® CLAMP SUB-ASSEMBLY
• M268S419B12061: MAYFIELD® Infinity Skull Clamp System Triad Rocker Arm
• M268S419B12051: MAYFIELD® Infinity Skull Clamp System Child Rocker Arm
• M268S419B12041: MAYFIELD® Infinity Skull Clamp System Adult Rocker Arm
• M268S419A12341: Child Rocker
• M268S419A12091: MAYFIELD® Infinity Skull Clamp System 80-lb Torque Screw
• M268S419A12081: MAYFIELD® Infinity Skull Clamp System Reduced Load 18-lb Torque Screw
• M268S419A12071: MAYFIELD® Infinity Skull Clamp System Single Pin Accessory
• M268S419A12501: MAYFIELD® Infinity Skull Clamp System Storage Case
• M268S419A12431: INFINITY BASE INSERT
• M268S419A12401: INFINITY 80 LB TORQUE KNOB
• M268S419A12391: INFINITY TORQUE SLEEVE
• M268S419A12381: 18 LB TORQUE KNOB
• M268S419A12371: 18 LB PISTON
• M268S419A12361: HANDLE BAR - INFINITY
• M268S419A12351: SINGLE PIN HOUSING - INFINITY
• M268S419A12331: PIN INSERT - INFINITY
• M268S419A12321: CLEVIS - INFINITY
• M268S419A12031: INFINITY RATCHET EXT. ASSEMBLY
• M268GS9711: Packing Set, A2114 Clamp
• M268GS9701: Transport Case
• M268GS9381: 6-32 SOC HD Cap SCR Stainless
• M268GS9371: 7/8-14 HELICAL INSERT
• M268GS9021: O-Ring 1.612" I.D. x .103" Thk.
• M268GS9011: POLYESTER FOAM CHARCOAL GRAY
• M268GS8631: .569" OD X .328" ID FLAT WASHER
• M268GS8621: CERAMIC BALLS
• M268GS8611: SPACER
• M268GS8361: FLAT HEAD SOCKET CAP SCREW