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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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Implant Cleaning Instrument
HAGER WORLDWIDE, INC.
355222
In Commercial Distribution

  • D2483552220 ()


  • Manual dental scaler, reusable
Implant Cleaning Instrument
HAGER WORLDWIDE, INC.
355221
In Commercial Distribution

  • D2483552210 ()


  • Manual dental scaler, reusable
Laser Box Product Number: HW003 laser Product number: HW049, HW050
C-Rad Positioning AB
HITMXY Red&Green
In Commercial Distribution

  • 17350005280120 ()


  • Laser patient positioning system
Laser Box Product Number: HW002 laser Product number: HW049, HW050
C-Rad Positioning AB
HITMX Red&Green
In Commercial Distribution

  • 17350005280090 ()


  • Laser patient positioning system
Laser Box Product Number: HW001 laser Product number: HW049, HW050
C-Rad Positioning AB
HIT Red&Green
In Commercial Distribution

  • 17350005280151 ()


  • Laser patient positioning system
QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft
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)
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 88
In Commercial Distribution

  • 09010522000984 ()
  • 09010522001943 ()
100747

  • Dental implant stability resonance frequency analysis peg
RECTANGLE, .88" x 3" x 5", 1 Each
TIDI PRODUCTS, LLC
33274
In Commercial Distribution

  • 00618125183685 ()


  • Multifunction body cushion
Envy NP9 Mattress (Alliance Style) 35" X 88"
SIZEWISE RENTALS, L.L.C.
ENVY NP93588
In Commercial Distribution

  • 00845699002603 ()


  • Flotation therapy bed, adult
SW Envy NPT3 Adapt (Alliance ) 35" x 88"
SIZEWISE RENTALS, L.L.C.
ENVY NPT33588
In Commercial Distribution

  • 00845699002597 ()


  • Flotation therapy bed, adult
CURETTE BONE LUCAS #88 D/E 7" 18CM
ACE SURGICAL SUPPLY CO., INC.
1000212
In Commercial Distribution

  • 00614950016600 ()

  • Length: 7 Inch
1000212

  • Bone curette, reusable
ZOOM™ 88 6F 088 LDP, 110 cm
IMPERATIVE CARE, INC.
ICFC088110
Not in Commercial Distribution


  • Lumen/Inner Diameter: 0.088 Inch
  • Outer Diameter: 0.108 Inch
  • Catheter Length: 110 Centimeter
ICFC088110

  • Vascular guide-catheter, single-use
  • Vascular microcatheter
ZOOM™ 88 6F 088 LDP, 100 cm
IMPERATIVE CARE, INC.
ICFC088100
Not in Commercial Distribution


  • Catheter Length: 100 Centimeter
  • Lumen/Inner Diameter: 0.088 Inch
  • Outer Diameter: 0.108 Inch
ICFC088100

  • Vascular guide-catheter, single-use
  • Vascular microcatheter
COE® McGowan-Winkler Complete Denture-Perforated Individual #88 Lower
Gc America Inc.
260881
In Commercial Distribution

  • 10386040012263 ()
260881

  • Dental impression tray, reusable
600 RECIPROCATING SAW BLADE 88 X 1.09 MM
ARTHREX, INC.
AR-600-200S
In Commercial Distribution

  • 00888867036758 ()
  • 10888867036755 ()
AR-600-200S

  • Surgical saw blade, reciprocating, single-use
BURKHART EXTRACTION FORCEPS 1-2 UPPER MOLAR ANAT #88
NORDENT MANUFACTURING INC
FE88L/BH
In Commercial Distribution

  • 00840018657496 ()


  • Tooth extraction forceps
88 LAB CARBIDE BURRS/TAPER 1/2" WIDTH
AMERICAN TOOTH INDUSTRIES
013-19797/L
In Commercial Distribution

  • D772ATI19797L0 ()


  • Diamond dental bur, reusable
COE® McGowan-Winkler Complete Denture-Perforated Individual #88 Lower
Gc America Inc.
260881
In Commercial Distribution

  • D6582608811 ()
260881

  • Dental impression tray, reusable
Cloverleaf Plate 3.5, 3 round holes, L 88
aap Implantate AG
PO 3515-03
Not in Commercial Distribution

  • 04042409066030 ()
PO 3515-03

  • Orthopaedic fixation plate, non-bioabsorbable
MedDrain 7mm Closed Wound Drain - Flat 88 Eyes
ARMM INC.
22237
In Commercial Distribution

  • 10850082007810 ()
  • 00850082007813 ()


  • Closed-wound drain, non-bioabsorbable
Rabbit Monoclonal Anti-Human CD34 (88),1 mL concentrated
Epitomics Inc.
AC-0082
In Commercial Distribution

  • 00810113062617 ()

  • Total Volume: 1 Milliliter


  • Multiple CD cell marker IVD, antibody
Rabbit Monoclonal Anti-Human CD34 (88), 0.1 mL concentrated
Epitomics Inc.
AC-0082A
In Commercial Distribution

  • 00810113062600 ()

  • Total Volume: 0.1 Milliliter


  • Multiple CD cell marker IVD, antibody
Rabbit Monoclonal Anti-Human CD34 (88), 0.5 mL concentrated
Epitomics Inc.
AC-0082B
In Commercial Distribution

  • 00810113062594 ()

  • Total Volume: 0.5 Milliliter


  • Multiple CD cell marker IVD, antibody
FreeClimb 88 catheter, 132cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 132cm (00853799007756)
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007770 ()
REF 7001-88-132

  • Vascular guide-catheter, single-use
FreeClimb 88 catheter, 125cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 125cm (00853799007749)
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007763 ()
REF 7001-88-125

  • Vascular guide-catheter, single-use
REUSE NUMBER OR DELETE
DANLEE MEDICAL PRODUCTS, INC
S0B2HH5ABFFLLPS
In Commercial Distribution

  • 00816310023024 ()


  • Electrocardiographic long-term ambulatory recording support kit
Retractor Number 5 Plus
Ortho Development Corporation
C-1729-55
In Commercial Distribution

  • 00822409108787 ()


  • Hand-held surgical retractor, reusable
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
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