CRW®

GUDID M248HRAIM1

Intubation Head Ring Assembly

INTEGRA LIFESCIENCES CORPORATION

Stereotactic radiosurgical invasive head frame
Primary Device IDM248HRAIM1
NIH Device Record Keyd769dfe5-36ba-4bcc-9434-d29dcd01f326
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRW®
Version Model NumberHRAIM
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780252283 [Primary]
HIBCCM248HRAIM1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

[M248HRAIM1]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-16
Device Publish Date2016-07-26

On-Brand Devices [CRW®]

M248S729025191LEXAN SUB COVER FOR CRW CASE
M248S729025171SR AND DA SILICONE STANDOFF HOLDER
M248S729011851RADEL LATCH, BLUE
M248SR1Ruler, 300mm
10381780511267Conical Screw Short, IMRIS
10381780412212Depth Stop 1.6mm
M248S729019841CASE PS2 MODIFIED
M248S729019781SWITCH ROTARY 1 POLE 2-12 POS
M248S723504501LUMINANT LOCALIZER SHIP CASE
M248S20211704011Dowel Pin, Titanium, 1/8" X .25
M248S20211704031DOWEL PIN, TITANIUM, 1/8"X .50
M248SHDWHS0816OC18-32X1/2 SS SOCKET CAP SCREW
M248S729010561LABEL,DESCENDING LOW TEMP
M248S729010551LABEL,HIGH TEMP,5 POINT
M248S20211704051DOWEL PIN, TITANIUM, 1/8"X .63
M248S20211704021DOWEL PIN, TITANIUM, 1/8"X .38
M248SHDWKN00231BLACK KNURLED KNOB,4X5/16"
M248S30215472110 - 32 X 1/2" Titanium Socket Cap Screw, Tamper-Proof
M248S202151581Mounting Ball, CRW Precise
M248SSUPTL00011HIGH SPEED GUN TAP, 3/8-16, H5
M248SSUPPROD01611CYANO ACRYLLA TE (SUPER GLUE)
M248SSCASS00011STAINLESS STEEL RULER, 300 MM
M248SHDWTI1016OC110-32 UNF-2AX1/2 SOCKET HEAD
M248SHDWTI1008OC110-32X1/4"TI, SOC.HD.CAP SCREW
M248SHDWTI0816OC18-32 UNC-2AX1/2 SOCKET HEAD
M248SHDWTI0812OC18-32 X 3/8" S.H.C.S.-TITANIUM"
M248SHDWTI0808OC18-32 X 1/4" S.H.C.S.-TITANIUM"
M248SHDWTI0406OS14-40x3/16" S.H.S.S Titanium
M248SHDWMI006018-32 S/S SPRING PLUNGER
M248SHDWHS0408OC14-40X1/4, S/S SOCKET CAP SCREW
M248SHDWHS0206SP12-56X3/16" SLOTTED PAN
M248SHDWHN0616SL1SCREW,SLOTTED,FH,6-32X1/2,NYLN
M248SHDWHN0612TS16-32X3/8" NYLON THUMB SCREW
M248SHDWHN0410PL1SCREW,FLAT HD,BLACK NYLON
M248SHDWFE00211RUBBER STEM BUMPER, EDPM M-2
M248SHDWDP00061DOWELL PINS S/S, 1/16 X 3/8"
M248SDRLSS00011DRILL, S/S, 2.7MM X 12"LONG"
M248S729027741CAL RETAINER, CRW PREC
M248S729027731CAL NAMEPLATE, CRW PREC
M248S729026781FOAM SET, CRW PREC. SYS. PACKAGING
M248S7290265911/4-20X3/8" TI FULL DOG PT SET SCREW
M248S729009971LL01,GEL ROD,6MM LONG
M248S729009961LL01,GEL ROD,9MM SHORT
M248S729009951LL01,GEL ROD,6MM SHORT
M248S7221513918-32 X 7/8" SOCKET CAP CAPTURE SCREW
M248S202113500511/16 X .150" TITANIUM DOWEL PIN
M248S202113500411/16 X .280" TITANIUM DOWEL PIN
M248S20211328021UCHR POST/HOOP SCREW
M248S20211328011UCHR POST/HOOP SCREW
M248S729026661STER. CASE SM TRAY, CRW PREC.
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.