CRW®

GUDID M433LTP1

Laser Target Pointer

INTEGRA LIFESCIENCES CORPORATION

Stereotactic radiosurgical invasive head frame

• Primary Device ID: M433LTP1
• NIH Device Record Key: ef23093a-5e61-4a9f-9974-e29022450fbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRW®
• Version Model Number: LTP
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES 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: 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
• 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
• 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	10381780252818 [Primary]
HIBCC	M433LTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100096
• Premarket Notification: K100417

FDA Product Code

• IYE: Accelerator, linear, medical
• MUJ: System, planning, radiation therapy treatment

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: 2020-01-13
• Device Publish Date: 2016-07-26

On-Brand Devices [CRW®]

• M248S729025191: LEXAN SUB COVER FOR CRW CASE
• M248S729025171: SR AND DA SILICONE STANDOFF HOLDER
• M248S729011851: RADEL LATCH, BLUE
• M248SR1: Ruler, 300mm
• 10381780511267: Conical Screw Short, IMRIS
• 10381780412212: Depth Stop 1.6mm
• M248S729019841: CASE PS2 MODIFIED
• M248S729019781: SWITCH ROTARY 1 POLE 2-12 POS
• M248S723504501: LUMINANT LOCALIZER SHIP CASE
• M248S20211704011: Dowel Pin, Titanium, 1/8" X .25
• M248S20211704031: DOWEL PIN, TITANIUM, 1/8"X .50
• M248SHDWHS0816OC1: 8-32X1/2 SS SOCKET CAP SCREW
• M248S729010561: LABEL,DESCENDING LOW TEMP
• M248S729010551: LABEL,HIGH TEMP,5 POINT
• M248S20211704051: DOWEL PIN, TITANIUM, 1/8"X .63
• M248S20211704021: DOWEL PIN, TITANIUM, 1/8"X .38
• M248SHDWKN00231: BLACK KNURLED KNOB,4X5/16"
• M248S302154721: 10 - 32 X 1/2" Titanium Socket Cap Screw, Tamper-Proof
• M248S202151581: Mounting Ball, CRW Precise
• M248SSUPTL00011: HIGH SPEED GUN TAP, 3/8-16, H5
• M248SSUPPROD01611: CYANO ACRYLLA TE (SUPER GLUE)
• M248SSCASS00011: STAINLESS STEEL RULER, 300 MM
• M248SHDWTI1016OC1: 10-32 UNF-2AX1/2 SOCKET HEAD
• M248SHDWTI1008OC1: 10-32X1/4"TI, SOC.HD.CAP SCREW
• M248SHDWTI0816OC1: 8-32 UNC-2AX1/2 SOCKET HEAD
• M248SHDWTI0812OC1: 8-32 X 3/8" S.H.C.S.-TITANIUM"
• M248SHDWTI0808OC1: 8-32 X 1/4" S.H.C.S.-TITANIUM"
• M248SHDWTI0406OS1: 4-40x3/16" S.H.S.S Titanium
• M248SHDWMI00601: 8-32 S/S SPRING PLUNGER
• M248SHDWHS0408OC1: 4-40X1/4, S/S SOCKET CAP SCREW
• M248SHDWHS0206SP1: 2-56X3/16" SLOTTED PAN
• M248SHDWHN0616SL1: SCREW,SLOTTED,FH,6-32X1/2,NYLN
• M248SHDWHN0612TS1: 6-32X3/8" NYLON THUMB SCREW
• M248SHDWHN0410PL1: SCREW,FLAT HD,BLACK NYLON
• M248SHDWFE00211: RUBBER STEM BUMPER, EDPM M-2
• M248SHDWDP00061: DOWELL PINS S/S, 1/16 X 3/8"
• M248SDRLSS00011: DRILL, S/S, 2.7MM X 12"LONG"
• M248S729027741: CAL RETAINER, CRW PREC
• M248S729027731: CAL NAMEPLATE, CRW PREC
• M248S729026781: FOAM SET, CRW PREC. SYS. PACKAGING
• M248S729026591: 1/4-20X3/8" TI FULL DOG PT SET SCREW
• M248S729009971: LL01,GEL ROD,6MM LONG
• M248S729009961: LL01,GEL ROD,9MM SHORT
• M248S729009951: LL01,GEL ROD,6MM SHORT
• M248S722151391: 8-32 X 7/8" SOCKET CAP CAPTURE SCREW
• M248S20211350051: 1/16 X .150" TITANIUM DOWEL PIN
• M248S20211350041: 1/16 X .280" TITANIUM DOWEL PIN
• M248S20211328021: UCHR POST/HOOP SCREW
• M248S20211328011: UCHR POST/HOOP SCREW
• M248S729026661: STER. CASE SM TRAY, CRW PREC.