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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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Status DS™ 9 card - 10743816000471

Status DS™ ME/O/C/TH/P//BZ/BA/TC/A card; 10 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-290-10-01
In Commercial Distribution

  • 10743816000471 ()
DOA-290-10-01

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical

Status DS™ 9 card - 10743816000464

Status DS™ ME/O/C/TH/P//BZ/BA/TC/A card; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-290-25-01
In Commercial Distribution

  • 10743816000464 ()
DOA-290-25-01

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical

WasherCap™ Countersink 9 mm - 08437019739584

Cannulated instrument used to shape the bone cortex to place de cap of the WasherCap™ Fixation System correctly. The countersink is composed by two parts (the stop and the body). Both parts must be assembled to compose the countersink to ensure that it can be used in accordance with its intended use. The countersink need to be disassembled during its reprocessing in order to facilitate the cleaning process. Prior to the steriliation process, both parts should be assembled again in order to prepare the countersink for its next use.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739584 ()
  • 28437019739588 ()


  • Surgical countersink, reusable

Filter/HME TwinStar 9 Plus - 04048675665908

No Description
Drägerwerk AG & Co. KGaA
MP05820
In Commercial Distribution

  • 04048675665908 ()


  • Heat/moisture exchanger/microbial medical gas filter

Prettau® Zirconia 9 High - D800ZRAD5501

Content: 1 piece Height: 22 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD5501
In Commercial Distribution

  • D800ZRAD5501 ()


  • Dental bridge, ceramic

Zirconia Translucent 16H16 (9 pieces) - D800ZRAB1039

No Description
ZIRKONZAHN SRL
ZRAB1039
In Commercial Distribution

  • D800ZRAB1039 ()


  • Dental bridge, ceramic

Zirconia Translucent 9 (2 pieces) - D800ZRAB0501

Content: 2 pieces Height: 16 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB0501
In Commercial Distribution

  • D800ZRAB0501 ()


  • Dental bridge, ceramic

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

BD SiteRite 9 Ultrasound System - 00801741227752

BD SiteRite 9 Cue Magnetizer
Bard Access Systems, Inc.
9770811
In Commercial Distribution

  • 00801741227752 ()
9770811

  • General-purpose ultrasound imaging system

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 - 00801741226311

BD SiteRite 9 Power Supply
Bard Access Systems, Inc.
9770813
In Commercial Distribution

  • 00801741226311 ()
9770813

  • 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

BD SiteRite 9 Ultrasound System - 00801741226243

BD SiteRite 9 Ultrasound System
Bard Access Systems, Inc.
9770800
In Commercial Distribution

  • 00801741226243 ()
9770800

  • General-purpose ultrasound imaging system

40442 Child Head Rest 9'' - 00787551004397

40442 Child Head Rest 9''
XODUS MEDICAL, INC.
40442
In Commercial Distribution

  • 20787551004391 ()
  • 00787551004397 ()
40442

  • Freestanding patient positioner, single-use

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

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

IN Abutment 4.5 X 9 - 07290109742410

IN Abutment 4.5 X 9
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742410 ()

  • Length: 9 Millimeter
BH-IB39

  • Dental implant suprastructure, permanent, preformed

IN Abutment 3.5 X 9 - 07290109742373

IN Abutment 3.5 X 9
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742373 ()

  • Length: 9 Millimeter
BH-IB29

  • Dental implant suprastructure, permanent, preformed

IN Abutment 3.0 X 9 - 07290109742335

IN Abutment 3.0 X 9
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742335 ()

  • Length: 9 Millimeter
BH-IB19

  • Dental implant suprastructure, permanent, preformed

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

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

Coutoured Carving Block Style 9 - M724CCB931

Coutoured Carving Block Style 9
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724CCB931 ()
CCB9-3

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 9 - M724CCB921

Contoured Carving Block Style 9
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724CCB921 ()
CCB9-2

  • Silicone-block tissue reconstructive material

Contoured Carving Block Style 9 - M724CCB911

Contoured Carving Block Style 9
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724CCB911 ()
CCB9-1

  • Silicone-block tissue reconstructive material

SANDBAG 3LB 9 X 7IN - 00733657244243

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

  • 00733657244243 ()
2970017440

  • Traction weight

Carbonic Anhydrase 9 Control Slides - B502BSB9055CS0

Carbonic Anhydrase 9 Control Slides
BIO SB, INC.
BSB-9055-CS
In Commercial Distribution

  • B502BSB9055CS0 ()
BSB-9055-CS

  • Carbonic anhydrase IVD, control

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

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

CHEMSTRIP 9 URINE TEST STRIPS - 00075537171097

No Description
Roche Diagnostics GmbH
11895427160
In Commercial Distribution

  • 00075537171097 ()
11895427160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

CHEMSTRIP 9 URINE TEST STRIPS - 00075537007433

No Description
Roche Diagnostics GmbH
11895397160
In Commercial Distribution

  • 00075537007433 ()
11895397160

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Retrax Retraction Cord 9/1 - 00310866000626

Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07910
In Commercial Distribution

  • 00310866000626 ()
07910

  • Gingival retraction cord, non-medicated

Racord Retraction Cord 9/1 - 00310866000541

Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07710
In Commercial Distribution

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated

Pascord Retraction Cord 9/1 - 00310866000503

Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07610
In Commercial Distribution

  • 00310866000503 ()
07610

  • Gingival retraction cord, non-medicated

Trial Head 15x18x10 9 deg. - 00810017913213

Trial Head 15x18x10 9 deg.
ELEVATION SPINE, INC.
CI-TH5891
In Commercial Distribution

  • 00810017913213 ()
CI-TH5891

  • Spinal implant trial

Trial Head 15x18x9 9 deg. - 00810017913206

Trial Head 15x18x9 9 deg.
ELEVATION SPINE, INC.
CI-TH5899
In Commercial Distribution

  • 00810017913206 ()
CI-TH5899

  • Spinal implant trial

Trial Head 15x18x8 9 deg. - 00810017913190

Trial Head 15x18x8 9 deg.
ELEVATION SPINE, INC.
CI-TH5898
In Commercial Distribution

  • 00810017913190 ()
CI-TH5898

  • Spinal implant trial
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