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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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Tinto Carbonic Anhydrase 9, RMab - B502BSB64170

Tinto Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB64170 ()
BSB 6417

  • Carbonic anhydrase IVD, antibody

Tinto Carbonic Anhydrase 9, RMab - B502BSB64160

Tinto Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB64160 ()
BSB 6416

  • Carbonic anhydrase IVD, antibody

Tinto Carbonic Anhydrase 9 RMab - B502BSB64150

Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB64150 ()
BSB 6415

  • Carbonic anhydrase IVD, antibody

9 Hole VL Tibia Plate - 00812926025506

No Description
Trilliant Surgical, LLC
300-62-002
In Commercial Distribution

  • 00812926025506 ()

  • 9 Hole VL Tibia Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

CERVICAL COIL N.9 SERV - 08056304452887

Coil for G-scan Brio Service
ESAOTE SPA
131000401
In Commercial Distribution

  • 08056304452887 ()


  • MRI system coil, radio-frequency

CERVICAL COIL N.9 SERV - 08056304452832

No Description
ESAOTE SPA
9102693101
In Commercial Distribution

  • 08056304452832 ()


  • MRI system coil, radio-frequency

Provox LaryTube 9/55, Fenestrated - 07331791002533

Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7641
In Commercial Distribution

  • 07331791002533 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7641

  • Tracheostomy tube, non-reinforced, non-customized, reusable

Provox LaryTube 9/36, Fenestrated - 07331791002519

Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7640
In Commercial Distribution

  • 07331791002519 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7640

  • Tracheostomy tube, non-reinforced, non-customized, reusable

9" ABD BINDER 46-62" BAGGED - 50610570190558

No Description
Bird & Cronin, LLC
90001762
In Commercial Distribution

  • 50610570190558 ()
  • 00610570190553 ()


  • Abdominal binder, single-use

9" COMFOR ABD BINDER 55-72" - 50610570002233

No Description
Bird & Cronin, LLC
08140372
In Commercial Distribution

  • 50610570002233 ()
  • 00610570002238 ()


  • Abdominal binder, single-use

9" COMFOR ABD BINDER 46-62" - 50610570002226

No Description
Bird & Cronin, LLC
08140362
In Commercial Distribution

  • 50610570002226 ()
  • 00610570002221 ()


  • Abdominal binder, single-use

BD SiteRite 9 Ultrasound System - 00801741227707

BD SiteRite 9 Ultrasound System (Refurbished)
Bard Access Systems, Inc.
9770800R
In Commercial Distribution

  • 00801741227707 ()
9770800R

  • General-purpose ultrasound imaging system

BD SiteRite 9 Ultrasound System - 00801741226274

BD SiteRite 9 Cue Linear Probe
Bard Access Systems, Inc.
9770803
In Commercial Distribution

  • 00801741226274 ()
9770803

  • General-purpose ultrasound imaging system

SapphireCool Light Guide 9 mm - 07290109141008

No Description
LUMENIS LTD.
SapphireCool Light Guide 9 mm
Not in Commercial Distribution

  • 07290109141008 ()


  • Multi-modality skin surface treatment system

TOTAL 5mm SOLUTION KIT 9 - 20607915127255

Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFB12, 5x100 Kii SH BLD ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK151
In Commercial Distribution

  • 20607915127255 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

LAP CHOLE KIT 9 GK - 20607915123646

Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK109-H
Not in Commercial Distribution

  • 20607915123646 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic

SANDBAG 3LB 9 X 7IN - 00733657244243

No Description
ALIMED, INC.
9-500
In Commercial Distribution

  • 00733657244243 ()
2970017440

  • Traction weight

ASSY,Reag.Disp.Card,PrepKit 9,BenchMark - 07613336125410

No Description
Ventana Medical Systems, Inc.
05251427001
In Commercial Distribution

  • 07613336125410 ()
05251427001

  • Assay container IVD, single-use

Quartet™ - 05414734503198

Left Heart Lead
ST. JUDE MEDICAL, INC.
1458Q-86
In Commercial Distribution

  • 05414734503198 ()

  • Length: 86 Centimeter
1458Q-86

  • Endocardial/interventricular septal pacing lead

S-Core™ - 00850017962262

9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink (00850017962569 and 00850017962507)
SUBCHONDRAL SOLUTIONS, INC.
10-2009-S
In Commercial Distribution

  • 10850017962269 ()
  • 00850017962262 ()

  • Height: 9 Millimeter
  • Length: 7.5 Millimeter
  • Outer Diameter: 9 Millimeter
10-2009-S

  • Orthopaedic bone screw, non-bioabsorbable, sterile

SPETZLER MACROVAC® - 00650551004516

9 FRENCH, 9 INCH LENGTH, TEARDROP TIP, WITH 90 DEGREE BEND NORTH, POLISHED FINISHED
PMT CORPORATION
3201-09T-09-095-PF
In Commercial Distribution

  • 00650551004516 ()


  • Surgical irrigation/aspiration handpiece, reusable

Sterile Lint Free Absorbent Wipers - 00843356102451

Sterile Lint Free Absorbent Wipers 9" X 9" Polyester Wipers - 2 Wipers per Pouch
CYGNUS MEDICAL L.L.C.
ST0909
In Commercial Distribution

  • 00843356102451 ()
  • 30843356102452 ()
  • 10843356102458 ()
  • 20843356102455 ()


  • Medical device cleaning/disinfection wipe

Ambler Surgical - 00190660184452

Fukushima tapered teardrop suction tube, 9 1/4", 9 French, angled, working length 178mm
AMBLER SURGICAL CORP.
89-626
In Commercial Distribution

  • 00190660184452 ()
89-626

  • Surgical/emergency suction cannula, non-illuminating, reusable

Ambler Surgical - 00190660184353

Fukushima tapered teardrop suction tube, 9 1/2", 9 French, malleable, working length 178mm
AMBLER SURGICAL CORP.
89-677
In Commercial Distribution

  • 00190660184353 ()
89-677

  • Surgical/emergency suction cannula, non-illuminating, reusable

CONCORDE - 10705034141565

CONCORDE INLINE SPINAL SYSTEM LORDOTIC IMPLANT STRAIGHT 9 x 9 x 25mm, 5 DEGREES
Medos International Sàrl
187850209
In Commercial Distribution

  • 10705034141565 ()
187850209

  • Polymeric spinal interbody fusion cage

CONCORDE - 10705034141428

CONCORDE INLINE SPINAL SYSTEM LORDOTIC IMPLANT STRAIGHT 9 x 9 x 21mm, 5 DEGREES
Medos International Sàrl
187850009
In Commercial Distribution

  • 10705034141428 ()
187850009

  • Polymeric spinal interbody fusion cage

CONCORDE - 10705034305578

CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 9 x 21/25mm, 0 DEGREES
DEPUY SPINE, LLC
287821009
Not in Commercial Distribution

  • 10705034305578 ()
287821009

  • Spinal implant trial

Iconix - 00190746116865

COSMETIC ICONIX UL LATERAL 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-7024BG
Not in Commercial Distribution

  • 00190746116865 ()
393-7024BG

  • Orthodontic bracket, metal

Iconix - 00190746116841

COSMETIC ICONIX UR LATERAL 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
393-7023BG
Not in Commercial Distribution

  • 00190746116841 ()
393-7023BG

  • Orthodontic bracket, metal

AESCULAP - 04038653047383

KERN-LANE Bone Holding Forceps, 9 1/2", (240 mm), width: 9 mm, non-sterile, reusable
Aesculap AG
FO150R
In Commercial Distribution

  • 04038653047383 ()
FO150R

  • Bone holding forceps
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