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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Suction Tube number 12
Avalign Technologies, Inc.
M1671635E
In Commercial Distribution

  • 00190776097165 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Suction Tube number 10
Avalign Technologies, Inc.
M1671645E
In Commercial Distribution

  • 00190776097158 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Suction Tube number 8
Avalign Technologies, Inc.
M1671646E
In Commercial Distribution

  • 00190776097141 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Suction Tube number 10
Avalign Technologies, Inc.
M9560534
In Commercial Distribution

  • 00190776096878 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Suction Tube number 6
Avalign Technologies, Inc.
M9560637
In Commercial Distribution

  • 00190776096854 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Retractor Number 5 Plus
Ortho Development Corporation
C-1729-55
In Commercial Distribution

  • 00822409108787 ()


  • Hand-held surgical retractor, reusable
REUSE NUMBER OR DELETE
DANLEE MEDICAL PRODUCTS, INC
S0B2HH5ABFFLLPS
In Commercial Distribution

  • 00816310023024 ()


  • Electrocardiographic long-term ambulatory recording support kit
Additional catalog number: 900-0456R
CEPHEID
INFINITY 48-40
In Commercial Distribution

  • 07332940006853 ()
900-0456

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0455R
CEPHEID
INFINITY 48-32
In Commercial Distribution

  • 07332940006846 ()
900-0455

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0454R
CEPHEID
INFINITY 48-24
In Commercial Distribution

  • 07332940006839 ()
900-0454

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0424R
CEPHEID
GXIV-2
In Commercial Distribution

  • 07332940004170 ()
900-0424

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0519R
CEPHEID
GXXVI-8
Not in Commercial Distribution

  • 07332940001469 ()
900-0519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0490R
CEPHEID
GXI-1
In Commercial Distribution

  • 07332940001360 ()
900-0490

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
DANIELS TONSILLECTOME NUMBER 1
TELEFLEX INCORPORATED
IPN002393
In Commercial Distribution

  • 24026704507515 ()
  • 04026704507511 ()

  • Length: 18 Centimeter
070600

  • Tonsillectome
SPACER INSERT NUMBER 3
Smith & Nephew, Inc.
71935123
In Commercial Distribution

  • 00885556577868 ()
71935123

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPACER INSERT NUMBER 2
Smith & Nephew, Inc.
71935122
In Commercial Distribution

  • 00885556577851 ()
71935122

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPACER INSERT NUMBER 1
Smith & Nephew, Inc.
71935121
In Commercial Distribution

  • 00885556577844 ()
71935121

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPACER INSERT NUMBER 0
Smith & Nephew, Inc.
71935120
In Commercial Distribution

  • 00885556577837 ()
71935120

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SUCKER 9569559 NUMBER 12
MEDTRONIC SOFAMOR DANEK, INC.
9569559
In Commercial Distribution

  • 00885074454221 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
Part number ULTRAQ_R_G , with green aiming beam , starting serial number URG
ELLEX MEDICAL PTY LTD
LQP3106-U
In Commercial Distribution

  • 09342395000427 ()


  • Ophthalmic solid-state laser system
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
BECTON, DICKINSON AND COMPANY
442021
In Commercial Distribution

  • 30382904420216 ()
  • 00382904420215 ()

  • Total Volume: 40 Milliliter
442021

  • Culture medium antimicrobial supplement IVD
BD BACTEC™ Standard/10 Aerobic/F Culture Vials, Case of 50 vials
BECTON, DICKINSON AND COMPANY
442027
In Commercial Distribution

  • 30382904420278 ()
  • 00382904420277 ()

  • Total Volume: 40 Milliliter
442027

  • Culture medium antimicrobial supplement IVD
MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365) that contains 6 individual MONTHLY MAINTENANCE KITs (Model Number 9717300; Primary DI Number 00851575007242)
HACH COMPANY
9756600
In Commercial Distribution

  • 00851575007365 ()
9756600

  • Haemodialysis system chlorine monitor
M - 90° White 90°
Darco (Europe) GmbH
PS2-90-1
In Commercial Distribution

  • 10609271245287 ()
  • 00609271245280 ()
  • 20609271245284 ()
PS2-90-1

  • Ankle/foot orthosis
S - 90° White 90°
Darco (Europe) GmbH
PS1-90-1
In Commercial Distribution

  • 10609271245188 ()
  • 00609271245181 ()
  • 20609271245185 ()
PS1-90-1

  • Ankle/foot orthosis
SKID ROD with HANDLE Use with Number 2/0 - Number 0 Suture
Medos International Sàrl
214502
In Commercial Distribution

  • 10886705003686 ()
214502

  • Orthopaedic guidewire, reusable
Narrow MC Plate 4.5, 5 ACP holes, L 88
aap Implantate AG
PG 4530-05-2
In Commercial Distribution

  • 04042409195501 ()
PG 4530-05-2

  • Orthopaedic fixation plate, non-bioabsorbable
Narrow MC Plate 4.5, 5 ACP holes, L 88
aap Implantate AG
PG 4530-05
In Commercial Distribution

  • 04042409195396 ()
PG 4530-05

  • Orthopaedic fixation plate, non-bioabsorbable
MedDrain 19 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222019
In Commercial Distribution

  • 10850082007711 ()
  • 00850082007714 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 15 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222015
In Commercial Distribution

  • 10850082007704 ()
  • 00850082007707 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 10 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222010
In Commercial Distribution

  • 10850082007674 ()
  • 00850082007677 ()


  • Closed-wound drain, non-bioabsorbable
MedDrain 7 Fr Closed Wound Drain - Round 88 Eyes
ARMM INC.
222070
In Commercial Distribution

  • 10850082007667 ()
  • 00850082007660 ()


  • Closed-wound drain, non-bioabsorbable
7.0 x 88 mm Headless, Cannulated, Short Thread Screw
Paragon 28, Inc.
P20-570-088S
In Commercial Distribution

  • 00889795008916 ()

  • 7.0 x 88 mm Headless, Cannulated, Short Thread Screw
  • Outer Diameter: 7 Millimeter
P20-570-088S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headless, Cannulated, Medium Thread Screw
Paragon 28, Inc.
P20-570-088M
In Commercial Distribution

  • 00889795008909 ()

  • 7.0 x 88 mm Headless, Cannulated, Medium Thread Screw
  • Outer Diameter: 7 Millimeter
P20-570-088M

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headless, Cannulated, Long Thread Screw
Paragon 28, Inc.
P20-570-088L
In Commercial Distribution

  • 00889795008893 ()

  • Outer Diameter: 7 Millimeter
  • 7.0 x 88 mm Headless, Cannulated, Long Thread Screw
P20-570-088L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Short Thread Screw
Paragon 28, Inc.
P20-170-088S
In Commercial Distribution

  • 00889795005786 ()

  • 7.0 x 88 mm Headed, Cannulated, Short Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Medium Thread Screw
Paragon 28, Inc.
P20-170-088M
In Commercial Distribution

  • 00889795005779 ()

  • 7.0 x 88 mm Headed, Cannulated, Medium Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088M

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Long Thread Screw
Paragon 28, Inc.
P20-170-088L
In Commercial Distribution

  • 00889795005762 ()

  • 7.0 x 88 mm Headed, Cannulated, Long Thread Screw
  • Outer Diameter: 7 Millimeter
P20-170-088L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
7.0 x 88 mm Headed, Cannulated, Full Thread Screw
Paragon 28, Inc.
P20-170-088F
In Commercial Distribution

  • 00889795005755 ()

  • Outer Diameter: 7 Millimeter
  • 7.0 x 88 mm Headed, Cannulated, Full Thread Screw
P20-170-088F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Alternating Pressure Mattress System, 88" x 36" x 8"
KAP MEDICAL
K-0MS8X88
In Commercial Distribution

  • 00817012020090 ()
K-0MS8X88

  • Low-air-loss bed
CAK XIII, C2 Clip Drape 88", 2xband 31x36", FSC
EXACT MEDICAL MANUFACTURING, INC.
E6005
Not in Commercial Distribution

  • 00816953027618 ()
  • 00816953027601 ()


  • Patient surgical drape, single-use
CAK VI, C2 Clip Drape 88", 2 Band 31x36"
EXACT MEDICAL MANUFACTURING, INC.
E6017
Not in Commercial Distribution

  • 00816953024938 ()
  • 00816953024921 ()
  • 00816953024945 ()


  • Patient surgical drape, single-use
CAK V, C2 Clip Drape 88", 2 Band 36x30"
EXACT MEDICAL MANUFACTURING, INC.
E6016
Not in Commercial Distribution

  • 00816953024907 ()
  • 00816953024891 ()
  • 00816953024914 ()


  • Patient surgical drape, single-use
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft
Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed
Philips Medical Systems Nederland B.V.
Zenition 90
In Commercial Distribution

  • 00884838112292 ()
718134

  • Mobile general-purpose fluoroscopic x-ray system, digital
Disposable accessory kit to be used with IntraVu Scope 90. Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock.
INTRAVU, INC.
IV-ASY-1609
In Commercial Distribution

  • 00850023905000 ()

  • Length: 90 Millimeter
IV-ASY-1609

  • Rigid optical arthroscope, single-use
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190015107 ()
138004st

  • Endoscopic surgical probe
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014131 ()
138004a

  • Endoscopic surgical probe
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190016746 ()
138004t

  • Endoscopic surgical probe
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