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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No Description
Sterilance Medical (Suzhou) Inc.
15#
In Commercial Distribution

  • 36945630112417 ()
  • 16945630112413 ()
  • 06945630112416 ()


  • Manual scalpel blade, single-use
Carbon Steel Surgical Blade,15#,100pcs/box
Sterilance Medical (Suzhou) Inc.
15#
In Commercial Distribution

  • 06945630105562 ()
  • 16945630105569 ()


  • Manual scalpel blade, single-use
PALLAS Premium Handpiece - 15 x 15
Laseroptek Co.,Ltd
PALLAS Premium Handpiece - 15 x 15
In Commercial Distribution

  • 08800035501792 ()


  • General/multiple surgical frequency-doubled solid-state laser system
15 cm, 15 Fr.
Spiggle & Theis Medizintechnik GmbH
30-748-15
In Commercial Distribution

  • 04250381814628 ()
30-748-15

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
Z-Staple 15 / 15 mm
Z-Medical GmbH + Co. KG
C03 208
In Commercial Distribution

  • 04057217003689 ()


  • Orthopaedic bone staple, non-adjustable
No Description
Berman Instruments LLC
ST530
Not in Commercial Distribution

  • 00810060723470 ()


  • Dental surgical probe, reusable
No Description
Berman Instruments LLC
ST153
Not in Commercial Distribution

  • 00810060723463 ()


  • Dental surgical probe, reusable
No Description
CareDx AB
101.516-04u
In Commercial Distribution

  • 07340035504344 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.516-24u
In Commercial Distribution

  • 07340035504320 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.125-06u
In Commercial Distribution

  • 07340035500148 ()


  • HLA class II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.125-24u
In Commercial Distribution

  • 07340035500124 ()


  • HLA class II antigen tissue typing IVD, kit, multiplex
Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK308
In Commercial Distribution

  • 20607915132044 ()


  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic
CRS Set 15
Candulor AG
662521
In Commercial Distribution

  • E1996625211 ()
662521

  • Dental articulator
No Description
MERCK MILLIPORE LIMITED
UFC901024D
In Commercial Distribution

  • 04061839736429 ()
  • 04061841163169 ()


  • Laboratory dialyser
No Description
MERCK MILLIPORE LIMITED
UFC901096D
In Commercial Distribution

  • 04061839736405 ()
  • 04061841040507 ()


  • Laboratory dialyser
No Description
MERCK MILLIPORE LIMITED
UFC901008D
In Commercial Distribution

  • 04061839736382 ()
  • 04061841163039 ()


  • Laboratory dialyser
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
3910-500-784
In Commercial Distribution

  • 10818674028742 ()
615300st

  • Clamp manipulation forceps
Scissors, 15°, Tube-shaft ValveGate™classic Ø5 25cm
Geister Medizintechnik GmbH
34-7830
In Commercial Distribution

  • 04057034122921 ()
34-7830

  • General-purpose surgical scissors, reusable
No Description
NARVA Lichtquellen GmbH + Co KG.
HPR 15FR71-T12-CA-160W
Not in Commercial Distribution

  • 84014501003936 ()
  • 54014501403933 ()
  • 04014501003930 ()
26117

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 102 0135-003 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy Weymouth, MA 02189, Phone: +1 781 331 0949, Email: kapgar@jwnorthamerica.com <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: office@narva-bel.de, http://www.narva-bel.de
NARVA Lichtquellen GmbH + Co KG.
HPR 15FR71-T12-CA-160W
Not in Commercial Distribution

  • 84014501003592 ()
  • 54014501403599 ()
  • 04014501003596 ()
26117

  • Ultraviolet tanning device
No Description
NARVA Lichtquellen GmbH + Co KG.
HPR 15FR71-T12-BA-120W
Not in Commercial Distribution

  • 84014501003585 ()
  • 54014501403582 ()
  • 04014501003589 ()
26118

  • Ultraviolet tanning device
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190010973 ()
PF1-0024

  • Dental implant system
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017934 ()
748231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014711 ()
748231a

  • Cast cutting shears
No Description
XIROS LTD
102-4015
In Commercial Distribution

  • 05060267131423 ()
n/a

  • Tendon/ligament bone anchor, non-bioabsorbable
Atellica IM Multi-Diluent 15
Siemens Healthcare Diagnostics Inc.
11200798
In Commercial Distribution

  • 00630414246826 ()
  • 00630414237701 ()
11200798

  • Buffered sample diluent IVD
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-113
Not in Commercial Distribution

  • 14953170183147 ()
  • 04953170183140 ()


  • Soft-tissue ultrasonic surgical system holder/tip, reusable
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
SARTORIUS STEDIM LAB LIMITED
VS15T02IVD
In Commercial Distribution

  • 05060602430082 ()
  • 05060602430341 ()


  • Centrifuge tube IVD
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
SARTORIUS STEDIM LAB LIMITED
VS15T01IVD
In Commercial Distribution

  • 05060602430075 ()
  • 05060602430341 ()


  • Centrifuge tube IVD
No Description
Dynarex Corporation
4135
In Commercial Distribution

  • 00616784413518 ()
  • 00616784413525 ()
  • 00616784413532 ()


  • Manual scalpel blade, single-use
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
ME-EC0015
In Commercial Distribution

  • 09421028119825 ()
ME-EC0015

  • Hand-held surgical retractor, reusable
No Description
IT-V Medizintechnik GmbH
P10107-513
In Commercial Distribution

  • 09120074395138 ()


  • Radiological whole-body positioner
No Description
OSADA ELECTRIC CO.,LTD.
Plugger set#15
In Commercial Distribution

  • 04582227397072 ()
81901

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Guidewire
FMD CO., LTD.
F18H15ST300
In Commercial Distribution

  • 14582233916240 ()
  • 04582233916243 ()

  • Length: 300 Centimeter
  • Outer Diameter: 0.018 Inch


  • Cardiac/peripheral vascular guidewire, single-use
Guidewire
FMD CO., LTD.
F18H15ST190
In Commercial Distribution

  • 14582233916233 ()
  • 04582233916236 ()

  • Length: 190 Centimeter
  • Outer Diameter: 0.018 Inch


  • Cardiac/peripheral vascular guidewire, single-use
Guidewire
FMD CO., LTD.
F14T15ST300
In Commercial Distribution

  • 14582233916189 ()
  • 04582233916182 ()

  • Length: 300 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use
Guidewire
FMD CO., LTD.
F14T15ST190
In Commercial Distribution

  • 14582233916172 ()
  • 04582233916175 ()

  • Length: 190 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use
No Description
MERCK MILLIPORE LIMITED
UFC901008
In Commercial Distribution

  • 04054839076800 ()
  • 04054839078514 ()


  • Laboratory dialyser
No Description
MERCK MILLIPORE LIMITED
UFC901096
In Commercial Distribution

  • 04054839076640 ()
  • 04054839078354 ()


  • Laboratory dialyser
No Description
MERCK MILLIPORE LIMITED
UFC901024
In Commercial Distribution

  • 04054839076633 ()
  • 04054839078347 ()


  • Laboratory dialyser
No Description
AB MEDICA GROUP, S.A.
1010001
In Commercial Distribution

  • 08428763004387 ()


  • Electrocardiographic recording paper
No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
51.4891
In Commercial Distribution

  • 18717872015931 ()
  • 08717872015934 ()
51.4891

  • Ophthalmic knife, single-use
Forceps
NOVASTEP
XFP03003
In Commercial Distribution

  • 03700879501024 ()
XFP03003

  • General internal orthopaedic fixation system implantation kit
Drill Guide
NOVASTEP
XDG01003
In Commercial Distribution

  • 03700879500836 ()
XDG01003

  • General internal orthopaedic fixation system implantation kit
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1515
In Commercial Distribution

  • 13700773723246 ()
  • 03700773723249 ()


  • Lacrimal intubation set
PROTEIN SEPARATION/FRACTIONALIZATION
SEBIA
4121
In Commercial Distribution

  • 03607360041215 ()
4121

  • Protein electrophoresis IVD, kit, electrophoresis
PROTEIN SEPARATION/FRACTIONALIZATION
SEBIA
4120
In Commercial Distribution

  • 03607360041208 ()
4120

  • Protein electrophoresis IVD, kit, electrophoresis
Size: 18 Hebeler x 15 mm
Boston Medical Products, Inc.
321187
Not in Commercial Distribution

  • EBES3211870 ()

  • Fits Size 18 mm Hebeler Safe-T-Tubes™
321187

  • Tracheostomy tube decannulation cap
Size: 15 Hebeler x 15 mm
Boston Medical Products, Inc.
321157
Not in Commercial Distribution

  • EBES3211570 ()

  • Fits Size 15 mm Hebeler Safe-T-Tubes™
321157

  • Tracheostomy tube decannulation cap
Size: 11-16 mm x 15 mm
Boston Medical Products, Inc.
321127
In Commercial Distribution

  • EBES3211270 ()

  • Fits Size 11-16 mm Montgomery® Safe-T-Tubes™ and 12 mm Hebeler Safe-T-Tubes™
321127

  • Tracheostomy tube decannulation cap
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