ELMED INCORPORATED ST5220412

GUDID 00198506025884

LAPAROSCOPIC PORT CLOSURE GUIDE CONE, 12 MM DIA., 10 CM. LENGTH, REUSABLE/AUTOCLAVABLE STAINLESS STEEL.

ELMED INCORPORATED

Laparoscopic multi-instrument access port, reusable
Primary Device ID00198506025884
NIH Device Record Key8fb043bf-cffa-4123-ab2e-8659741aca03
Commercial Distribution StatusIn Commercial Distribution
Brand NameELMED INCORPORATED
Version Model NumberST5220412
Catalog NumberST5220412
Company DUNS049290364
Company NameELMED INCORPORATED
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

Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com
Phone224-353-6446
Emailmedical@elmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100198506025884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

[00198506025884]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-25
Device Publish Date2024-09-17

On-Brand Devices [ELMED INCORPORATED]

001985060599335MM, 45CM, HUNTER DEBAKEY, FENESTRATED, 30MM, ROTATABLE, ONE PIECE W/ FLUSHPORT
00198506059926Debakey Heparin Needle Large, Malleable, 4mm Distal Tip with 4 lateral holes and one distal hole
00198506059919FIBER OPTIC RETRACTOR; TEBBET STYLE, 3CM X 9CM, W/ SUCTION, RIGHT ANGLE TAPERED TIP W/ TEETH
001985060599025 Fr. (1.6 mm) 40cm, Alligator Grasping Forceps Semi-Rigid
0019850605989610 MM DIA., 37.5 CM, ANVIL GRASPER WITH SPECIAL SHAPED JAWS TO GRASP AND HOLD THE ANVIL OF A CIR
00198506059872NATHANSON PEDI LIVER RETRACTOR 3.0MM, SMALL -->"REF: 69735-3"
00198506059681SCISSORS, CURVED UP 45 DEG
00198506059674SCISSORS, CURVED UP 150
00198506059667SCISSORS, STRAIGHT
00198506059650ALLIGATOR FORCEPS, SERRATED, STRAIGHT
00198506059971T/C NEEDLE HOLDER; VASCULAR, 6", SLENDER
00198506059964T/C NEEDLE HOLDER; VASCULAR, 6", DELICATE/SLENDER
001985060599573.4MM DIAMETER GRASPING FORCEP RING HANDLE W/ RATCHET
00198506060052HEMOSTATIC FORCEPS, ROCHESTER-OCHSNER, 1X2 TEETH, CURVED, 18CM
00198506060045UNIVERSAL SCOPE HOLDER W/ POSITIVE SCOPE ARTICULATION AND CHEST BAR, DIRECT MOUNTING FOR SCOPES
00198506060021Reul Coronary Tissue Forcep, 8", Carbite Tip, Delicate
00198506060014UNIVERSAL SPRING FOR KERRISON RONGEUR CLEAR FLUSH HANDLE
00198506060007Wolf Suction Irrigation Handle, Refurbished
001985060601135MM, 33CM, REUSABLE IRRIGATION/SUCTION SYSTEM WITH TWO-WAY LEVER VALVE AND CANNULA, OPEN TIP SUC
00198506060106ELMED MICRO BIPOLAR FORCEPS, 2-PIN CONNECTOR, MCPHERSON STRAIGHT, 4 1/4" (8.5CM) INSULATED, CURV
00198506060175ELMED REUSABLE MONOPOLAR FRAZIER SUCTION COAGULATOR CODMAN STYLE 90 DEG. ANGLE + CABLE SCREW ON
00198506060151ELMED REUSABLE MONOPOLAR FRAZIER SUCTION COAGULATOR CODMAN STYLE 90 DEG. ANGLE + CABLE SCREWON P
001985060269735 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, SIDE MOUNT RF CONNECTOR
001985060603805MM, 24CM, KELLY GRASPER 14MM TIP, ROTATABLE, ONE-PIECE W/ FLUSHPORT, TYPE 5 HANDLE: INSULATED W
0019850606037310MM DIA., 41CM, ESOPHAGEAL RETRACTOR-GASTRIC BAND MANIPULATOR, 90 DEG., ANGULATION, WITH RING R
00198506060311LAP, SUCTION, POOLE-TIP, 10MM, 32CM
00198506060304INSULATED AUVARD VAGINAL SPECULUM WITH SLOTTED SMOKE DISPOSABLE VACUATION TUBE, 4 X 1-3/4", 9"
00198506060298INSULATED JACKSON VAGINAL RETRACTORS - LARGE, SINGLE-ENDED, 4 X 1-1/2", WITH SLOTTED SMOKE TUBE,
001985060602813MM (3/32”) Ø SHAFT, 5" SHAFT EXTENSION, FULLY INSULATED, STD. / UNIVERSAL ELECTRODE STRAIGHT
001985060602743MM (3/32”) Ø SHAFT, 3" SHAFT EXTENSION, FULLY INSULATED, STD. / UNIVERSAL ELECTRODE STRAIGHT
001985060602506.3MM O.D., 3.5" (89MM) LENGTH OBTURATOR
00198506060243CYSTOSCOPY FLEXIBLE ELECTRODE; 6FR X 35CM, BALL TIP, COLOR CODE GREEN
00198506060229OUTER CANNULA, PRESSURE SENSING SCOPE SHEATH
00198506060212SURGICAL DUAL STOPCOCK INNER SHEATH
00198506060205FIBER OPTIC CABLE, STORZ INSTRUMENT CONNECTOR & STORZ LIGHT SOURCE CONNECTION
001985060601994mm, 55cm Working Length, Suction Tube w/ Cut-Of
001985060601823mm, 35cm Working Length, Suction Tube w/ Cut-Off
00198506060519METZ. SCISSORS SINGLE ACTION SEMI-RIGID 7 fr
00198506060496Outer Tube, Stainless Steel, 14mm Outer Sheath, 55cm Working Length
00198506060489SPECIAL MADE SUCTION TUBE, 10" OL, 10MM TUBING, ROUND THUMB CONTROL VALVE, PROXIMAL BARB FITTING
00198506060472FIBER OPTIC LIGHT CARRIER FOR P/N: 522229 LARYNGOSCOPE HANDLE
00198506060458Silver Select Slim-Line Bayonet Bipolar Forceps-Insulated Black, 8 7/8”, 2-pin cable connector
00198506048425BASE, LID & MAT, 2.5 X 7.5 X 0.75
00198506040474IRRIGATION ADAPTER W/TUBE CONNECTION
00842180147966FIBEROPTIC DEEP PELVIC RETRACTOR, STANDARD, UPPER BLADE 65MM, LOWER BLADE 50MM, UNIVERSAL CABLE
00198506060885ELMED NATHANSON STYLE LIVER RETRACTORS, 5MM DIA. - SIZE: LARGE (MEDIFLEX STYLE)
001985060608782.5mm, 55cm, Alligator Grasper
001985060608612.5mm, 55cm, Peanut Grasper
00198506060847VEIN RETRACTOR, 6" BLADE LENGTH, ROUNDED ANGLED DOWN TIP, 21.5MM CONCAVED BLADE, TEARDROP HANDLE
00198506060830Cushing Forceps, 1 x 2 Teeth, 10"
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