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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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Multistix® 9 Reagent Strips - 00630414549019

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
10329874
In Commercial Distribution

  • 00630414549019 ()
  • 00630414009629 ()
A2162B16

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

Feed Base 9 Medium - 2kg - 05407010125139

No Description
Lonza Verviers
BESP1685X2
In Commercial Distribution

  • 05407010125139 ()


  • Ex vivo cell culture medium

Tapia adenoid spatula, 9 holes - 04250381888728

No Description
Spiggle & Theis Medizintechnik GmbH
40-510-01
In Commercial Distribution

  • 04250381888728 ()
40-510-01

  • General-purpose surgical spatula

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

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

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

StarGuard Suture Retention Plates - 9" - 00810805000231

For the temporary, external anchoring of sutures and prevention of suture pull through.
PRESERVATION SOLUTIONS INC
SG-9
In Commercial Distribution

  • 00810805000231 ()


  • Suture retention device

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

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

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

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

SMARTFIT FINAL HYBRID DENTURE - 9 - 00810126042057

No Description
HIOSSEN, INC.
FNLHYD09
In Commercial Distribution

  • 00810126042057 ()


  • Dental implant suprastructure, temporary, preformed, single-use

#9 – Straight Needle, Sharp Tip - 00840096203981

#9 – Straight Needle, Sharp Tip
KATALYST SURGICAL LLC
N088-080
In Commercial Distribution

  • 00840096203981 ()


  • Suturing needle holder, reusable

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

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

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

WOLF Plate, 122mm, 9 Hole - 00816101011957

The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101011957 ()
TO-LBP-122

  • Orthopaedic fixation plate, non-bioabsorbable

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

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

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

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
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