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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Phenom™ Catheter - 00814584024013

Phenom™ 27 Catheter
CATHERA, INC.
FG15150-1030-1SV01
Not in Commercial Distribution

  • 00814584024013 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 150 Centimeter
FG15150-1030-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584024006

Phenom™ 27 Catheter
CATHERA, INC.
FG15150-0630-1SV01
Not in Commercial Distribution

  • 00814584024006 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 150 Centimeter
FG15150-0630-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023993

Phenom™ 27 Catheter
CATHERA, INC.
FG15150-1015-1SV01
Not in Commercial Distribution

  • 00814584023993 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 150 Centimeter
FG15150-1015-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023986

Phenom™ 27 Catheter
CATHERA, INC.
FG15150-0615-1SV01
Not in Commercial Distribution

  • 00814584023986 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 150 Centimeter
FG15150-0615-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023979

Phenom™ 27 Catheter
CATHERA, INC.
FG15135-1030-1SV01
Not in Commercial Distribution

  • 00814584023979 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 135 Centimeter
FG15135-1030-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023962

Phenom™ 27 Catheter
CATHERA, INC.
FG15135-0630-1SV01
Not in Commercial Distribution

  • 00814584023962 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 135 Centimeter
FG15135-0630-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023955

Phenom™ 27 Catheter
CATHERA, INC.
FG15135-1015-1SV01
Not in Commercial Distribution

  • 00814584023955 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 135 Centimeter
FG15135-1015-1S

  • Vascular guide-catheter, single-use

Phenom™ Catheter - 00814584023948

Phenom™ 27 Catheter
CATHERA, INC.
FG15135-0615-1SV01
Not in Commercial Distribution

  • 00814584023948 ()

  • Lumen/Inner Diameter: 0.027 Inch
  • Length: 135 Centimeter
FG15135-0615-1S

  • Vascular guide-catheter, single-use

Centurion - 10653160315483

LVAD MANAGEMENT SYSTEM 2-7
CENTURION MEDICAL PRODUCTS CORPORATION
DM280A
In Commercial Distribution

  • 00653160315486 ()
  • 10653160315483 ()
DM280A

  • General surgical procedure kit, medicated

Techno-Aide - G242YFBF9

27° SPINAL WEDGE SPONGE
Techno-Aide, Inc.
YFBF
In Commercial Distribution

  • G242YFBF90 ()
  • G242YFBF9 ()
YFBF

  • Radiological general body-part positioner

Powerline Acessory - 00817463027136

27" Powerline Table Extender
OAKWORKS, INC.
44677
In Commercial Distribution

  • 00817463027136 ()


  • Radiology table extension

HELMUT ZEPF - EZPF17627000

ROOT ELEVATOR, NO. 27,
Helmut Zepf Medizintechnik GmbH
17.627.00
In Commercial Distribution

  • EZPF17627000 ()
17.627.00

  • Dental elevator, tooth/root

J & J INSTRUMENTS INC - 00817524020694

BURNISHER DE #27/29
J & J INSTRUMENTS INC
02-510
In Commercial Distribution

  • 00817524020694 ()

  • Length: 6.5 Inch
02-510

  • Manual dental burnisher, reusable

Centurion Medical Products Corp - 10653160997375

LVAD MANAGEMENT SYSTEM 2-7
MEDLINE INDUSTRIES, INC.
DM1325
In Commercial Distribution

  • 40653160997376 ()
  • 10653160997375 ()
DM1325

  • General surgical procedure kit, non-medicated, single-use

Small Antenna 27" Length - 00818225020525

Small Antenna 27" Length
STIMWAVE TECHNOLOGIES INCORPORATED
MD0725-27-SS
In Commercial Distribution

  • 00818225020525 ()

  • Length: 68.58 Centimeter
  • Length: 27 Inch


  • Multiple active implantable device programmer

SafeGuide® - 00816734021071

Esophageal Dilator, 27 French
DIVERSATEK HEALTHCARE, INC.
1214-27
In Commercial Distribution

  • 00816734021071 ()

  • Catheter Gauge: 27 French
1214-27

  • Over-guidewire oesophageal dilator

NA - 07332747023237

Screwdriver Hexagon 27 mm
Nobel Biocare AB
DIA 313-0
In Commercial Distribution

  • 07332747023237 ()

  • Length: 27.000 Millimeter
DIA 313-0

  • Surgical screwdriver, reusable

Truform - 00885797092373

MOLAR BAND MAN 27
Rmo, Inc.
B00651
In Commercial Distribution

  • 00000008857972 ()
  • 00885797092373 ()


  • Orthodontic metal band

Truform - 00885797092052

MOLAR BAND MAX 27
Rmo, Inc.
B00619
In Commercial Distribution

  • 00000008857972 ()
  • 00885797092052 ()


  • Orthodontic metal band

Bradshaw Medical Inc. - 00810019930249

BIT, HEXALOBE 27 AO
Bradshaw Medical, Inc.
920-0308
In Commercial Distribution

  • 00810019930249 ()
920-0308

  • Surgical screwdriver, reusable

NA - 07332747214581

Screwdriver Hexagon 27 mm
Nobel Biocare AB
DIA 313-0
In Commercial Distribution

  • 07332747214581 ()

  • Length: 27.000 Millimeter
DIA 313-0

  • Surgical screwdriver, reusable

Laserneedle Touch - 04260649160046

Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)
Laserneedle GmbH
12000-Trolley
In Commercial Distribution

  • 04260649160046 ()


  • Musculoskeletal/physical therapy laser, professional

GETINGE 86-SERIES - 07340153700260

WASHER DISINFECTOR Catalog number was S-86681001. Catalog number updated to S-86682001 in November 2018.
Getinge Disinfection AB
S-8668
In Commercial Distribution

  • 07340153700260 ()
S-86682001

  • Surgical utensil washer/disinfector

GETINGE 86-SERIES - 07340153700246

WASHER DISINFECTOR Catalog number was S-86661001. Catalog number updated to S-86662001 in November 2018.
Getinge Disinfection AB
S-8666
In Commercial Distribution

  • 07340153700246 ()
S-86662001

  • Surgical utensil washer/disinfector

Hu-Friedy MFG Co., LLC. - 10889950032470

#7/8 After-Five Gracey Curette R8 Hdl
HU-FRIEDY MFG. CO., LLC
SRPG7/88
In Commercial Distribution

  • 10889950032470 ()


  • Periodontal curette

Hu-Friedy MFG Co., LLC. - 10889950033293

#YG7/8 Younger-Good Curette, ResinEight
HU-FRIEDY MFG. CO., LLC
SYG7/88
In Commercial Distribution

  • 10889950033293 ()


  • Periodontal curette

Hu-Friedy MFG Co., LLC. - 10889950026998

#7/8 Gracey Curette, ResinEight Hdl
HU-FRIEDY MFG. CO., LLC
SG7/88
In Commercial Distribution

  • 10889950026998 ()


  • Periodontal curette

Hu-Friedy MFG Co., LLC. - 10889950024246

#7/8 Mini Five Gracey Curette, R8 Hdl
HU-FRIEDY MFG. CO., LLC
SAS7/88
In Commercial Distribution

  • 10889950024246 ()


  • Periodontal curette

HU-FRIEDY - 10889950018474

Dietschi Composite Inst #7/8 #8 HDL
HU-FRIEDY MFG. CO., LLC
PFIDD7/88
In Commercial Distribution

  • 10889950018474 ()
PFIDD7/88

  • Dental restoration carver, resin

Dental System - 05902729752794

Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.x.y
Not in Commercial Distribution

  • 05902729752794 ()


  • CAD/CAM software

LINK Endo-Model EVO Knee System - 04026575275458

Modular stem, uncemented, Ti6Al4V, cylindrical (EVO)
WALDEMAR LINK GmbH & Co. KG
15-2951/88
In Commercial Distribution

  • 04026575275458 ()


  • Knee femur stem prosthesis

MEDENTiKA - EMKAM889

Tool Kit
MEDENTiKA GmbH
M 88
In Commercial Distribution

  • 04251574837554 ()
  • EMKAM889 ()

  • compatible with Medentika
M 88

  • Surgical screwdriver, reusable

MagPro - 05713484020437

Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an accessory to the predicate MagVenture TMS Therapy System (K150641, K171481 and K171967).
Tonica Elektronik A/S
Cool-B65 CO
In Commercial Distribution

  • 05713484020437 ()
9016E0151

  • Magnetic neural stimulation system

Philips one - 00075020102300

No Description
PHILIPS ORAL HEALTHCARE, LLC
PAL109/CO
In Commercial Distribution

  • 00075020102300 ()


  • Basic electric toothbrush

Philips MR Patient Care LoFlo Cannula Line - 00607411982040

MR Oatient Care Pediatric LoFlo CO/O2 Cannula
SALTER LABS
P183281
In Commercial Distribution

  • 10607411982047 ()
  • 00607411982040 ()
989803183281

  • Nasal oxygen cannula, carbon-dioxide-sampling

TELEFLEX - 14026704713759

White/Green Co Braid Size 3.5mm 30" Medshape
TELEFLEX INCORPORATED
IPN001120
In Commercial Distribution

  • 24026704713756 ()
  • 14026704713759 ()
1700-02-000

  • Polyolefin/fluoropolymer suture, multifilament

QUIKCORD - 14026704596390

White/Green Co Braid Size 3.5mm 30" Medshape
TELEFLEX INCORPORATED
IPN001120
In Commercial Distribution

  • 24026704596397 ()
  • 14026704596390 ()

  • Suture Length 30"
1700-02-000

  • Polyolefin/fluoropolymer suture, multifilament

IMS - 10889950056537

SPECIAL 8-INSTR SIG,YEL/WHT BASE,BLUE CO
HU-FRIEDY MFG. CO., LLC
IM508528
Not in Commercial Distribution

  • 10889950056537 ()
IM508528

  • Device sterilization/disinfection container, reusable

MEDLINE - 10888277374201

4617 @ARTSPC CAN SET W/DISTAL HOLES & CO
MEDLINE INDUSTRIES, INC.
4617R
In Commercial Distribution

  • 20888277374208 ()
  • 10888277374201 ()
4617R

  • Laparoscopic access cannula, reprocessed

Medline Industries, Inc. - 10884389349045

OR CLN UP KIT VAN MERT CO HOSP
MEDLINE INDUSTRIES, INC.
DYK1016081C2
In Commercial Distribution

  • 10884389349045 ()
DYK1016081C2

  • General surgical procedure kit, non-medicated, reusable
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