Primary Device ID | 00198506060281 |
NIH Device Record Key | 906cecd5-8e76-4eff-882d-78b04578ee50 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ELMED INCORPORATED |
Version Model Number | 5430-09 |
Catalog Number | 5430-09 |
Company DUNS | 049290364 |
Company Name | ELMED INCORPORATED |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | true |
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 |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com | |
Phone | 224-353-6446 |
medical@elmed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00198506060281 [Primary] |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
[00198506060281]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-07 |
Device Publish Date | 2024-07-30 |
00198506059933 | 5MM, 45CM, HUNTER DEBAKEY, FENESTRATED, 30MM, ROTATABLE, ONE PIECE W/ FLUSHPORT |
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00198506059896 | 10 MM DIA., 37.5 CM, ANVIL GRASPER WITH SPECIAL SHAPED JAWS TO GRASP AND HOLD THE ANVIL OF A CIR |
00198506059872 | NATHANSON PEDI LIVER RETRACTOR 3.0MM, SMALL -->"REF: 69735-3" |
00198506059681 | SCISSORS, CURVED UP 45 DEG |
00198506059674 | SCISSORS, CURVED UP 150 |
00198506059667 | SCISSORS, STRAIGHT |
00198506059650 | ALLIGATOR FORCEPS, SERRATED, STRAIGHT |
00198506059971 | T/C NEEDLE HOLDER; VASCULAR, 6", SLENDER |
00198506059964 | T/C NEEDLE HOLDER; VASCULAR, 6", DELICATE/SLENDER |
00198506059957 | 3.4MM DIAMETER GRASPING FORCEP RING HANDLE W/ RATCHET |
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00198506060045 | UNIVERSAL SCOPE HOLDER W/ POSITIVE SCOPE ARTICULATION AND CHEST BAR, DIRECT MOUNTING FOR SCOPES |
00198506060021 | Reul Coronary Tissue Forcep, 8", Carbite Tip, Delicate |
00198506060014 | UNIVERSAL SPRING FOR KERRISON RONGEUR CLEAR FLUSH HANDLE |
00198506060007 | Wolf Suction Irrigation Handle, Refurbished |
00198506060113 | 5MM, 33CM, REUSABLE IRRIGATION/SUCTION SYSTEM WITH TWO-WAY LEVER VALVE AND CANNULA, OPEN TIP SUC |
00198506060106 | ELMED MICRO BIPOLAR FORCEPS, 2-PIN CONNECTOR, MCPHERSON STRAIGHT, 4 1/4" (8.5CM) INSULATED, CURV |
00198506060175 | ELMED REUSABLE MONOPOLAR FRAZIER SUCTION COAGULATOR CODMAN STYLE 90 DEG. ANGLE + CABLE SCREW ON |
00198506060151 | ELMED REUSABLE MONOPOLAR FRAZIER SUCTION COAGULATOR CODMAN STYLE 90 DEG. ANGLE + CABLE SCREWON P |
00198506026973 | 5 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, SIDE MOUNT RF CONNECTOR |
00198506060380 | 5MM, 24CM, KELLY GRASPER 14MM TIP, ROTATABLE, ONE-PIECE W/ FLUSHPORT, TYPE 5 HANDLE: INSULATED W |
00198506060373 | 10MM DIA., 41CM, ESOPHAGEAL RETRACTOR-GASTRIC BAND MANIPULATOR, 90 DEG., ANGULATION, WITH RING R |
00198506060311 | LAP, SUCTION, POOLE-TIP, 10MM, 32CM |
00198506060304 | INSULATED AUVARD VAGINAL SPECULUM WITH SLOTTED SMOKE DISPOSABLE VACUATION TUBE, 4 X 1-3/4", 9" |
00198506060298 | INSULATED JACKSON VAGINAL RETRACTORS - LARGE, SINGLE-ENDED, 4 X 1-1/2", WITH SLOTTED SMOKE TUBE, |
00198506060281 | 3MM (3/32”) Ø SHAFT, 5" SHAFT EXTENSION, FULLY INSULATED, STD. / UNIVERSAL ELECTRODE STRAIGHT |
00198506060274 | 3MM (3/32”) Ø SHAFT, 3" SHAFT EXTENSION, FULLY INSULATED, STD. / UNIVERSAL ELECTRODE STRAIGHT |
00198506060250 | 6.3MM O.D., 3.5" (89MM) LENGTH OBTURATOR |
00198506060243 | CYSTOSCOPY FLEXIBLE ELECTRODE; 6FR X 35CM, BALL TIP, COLOR CODE GREEN |
00198506060229 | OUTER CANNULA, PRESSURE SENSING SCOPE SHEATH |
00198506060212 | SURGICAL DUAL STOPCOCK INNER SHEATH |
00198506060205 | FIBER OPTIC CABLE, STORZ INSTRUMENT CONNECTOR & STORZ LIGHT SOURCE CONNECTION |
00198506060199 | 4mm, 55cm Working Length, Suction Tube w/ Cut-Of |
00198506060182 | 3mm, 35cm Working Length, Suction Tube w/ Cut-Off |
00198506060519 | METZ. SCISSORS SINGLE ACTION SEMI-RIGID 7 fr |