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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No Description
W.H. Holden, Inc.
10-5199-9CH
In Commercial Distribution

  • D9281051999CH0 ()


  • Dental osteotome set
The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.
OSTEOTEC LIMITED
OSTF-9
In Commercial Distribution

  • 05060183090101 ()
OSTF-9

  • Metacarpophalangeal/proximal interphalangeal joint prosthesis
Alkaline Wash Solution should be used in conjunction with reagents to clean cuvettes
RANDOX LABORATORIES LIMITED
RX8130
In Commercial Distribution

  • 05055273215007 ()
RX8130

  • Wash/cleaning solution IVD, automated/semi-automated system
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
Not in Commercial Distribution

  • 00310866000589 ()
07810

  • Gingival retraction cord, medicated
Braided gingival retraction cord with epinephrine, 72 inches, size 9/1
PASCAL COMPANY, INC.
07210
In Commercial Distribution

  • 00310866000381 ()
07210

  • Gingival retraction cord, medicated
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
In Commercial Distribution

  • 00310866002422 ()
07810

  • Gingival retraction cord, medicated
Untreated Braided Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07410
In Commercial Distribution

  • 00310866000466 ()
07410

  • Gingival retraction cord, non-medicated
Braided Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size:9/1,
PASCAL COMPANY, INC.
07310
In Commercial Distribution

  • 00310866000428 ()
07310

  • Gingival retraction cord, medicated
Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07110
In Commercial Distribution

  • 00310866000343 ()
07110

  • Gingival retraction cord, non-medicated
No Description
MedXpert GmbH
014-01009
In Commercial Distribution

  • 04260029580921 ()
014-01009

  • Rib/rib cage internal fixation/bracing system fixation grip/anchor
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-1601-9 G
In Commercial Distribution

  • 04049016124900 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-6401-9 G
In Commercial Distribution

  • 04049016124917 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5947804
In Commercial Distribution

  • 04049098008013 ()
  • 04049098058223 ()


  • Electrocardiographic lead set, reusable
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
Trilliant Surgical, LLC
300-60-002
In Commercial Distribution

  • 00812926025445 ()

  • 9 Hole VL Gridlock Fibula Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Medshape, Inc.
2200-19-0020
In Commercial Distribution

  • M97022001900200 ()


  • Orthopaedic bone-fragment manipulator, single-use
STOP H.9 MM FOR DRILL M.I.S.E. EVO KIT
SWEDEN & MARTINA SPA
KM-S-09
In Commercial Distribution

  • D7701022023 ()
KM-S-09

  • Dental implant/prosthesis surgical procedure kit
RUBBER DAM CLAMP (1/pack) Material: Spring tempered stainless steel, Size: 9; For more information: https://www.scottsdental.com/rubber-dam-clamps-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
144-C9
In Commercial Distribution

  • D778144C90 ()
144-C9

  • Rubber dam clamp
Oval Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Oval w/support # 9
In Commercial Distribution

  • M803050119 ()
050119

  • Pelvic-organ-supporting pessary
Cube Pessary is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Cube w/drain # 9
In Commercial Distribution

  • M803050075 ()
050075

  • Pelvic-organ-supporting pessary
Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #9
In Commercial Distribution

  • M803050034 ()
050034

  • Pelvic-organ-supporting pessary
No Description
Laborie Medical Technologies Canada ULC
9021P5091
In Commercial Distribution

  • 20627825007102 ()
  • 10627825007105 ()
  • 30627825007109 ()


  • Urodynamic manometric catheter, non-electronic
The Direct Fluorescent Antibody Reagents are intended for the presumptive (serological) identification of Legionella pneumophila serogroups 2 through 14 from culture isolates.
PRO-LAB, INCORPORATED
PL.278
In Commercial Distribution

  • 10628429001872 ()
PL.278

  • Legionella pneumophila nucleic acid IVD, reagent
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1054
In Commercial Distribution

  • 07640136270132 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1053
In Commercial Distribution

  • 07640136270125 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1052
In Commercial Distribution

  • 07640136270118 ()


  • External orthopaedic fixation system, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1026
In Commercial Distribution

  • 07640136270040 ()


  • External orthopaedic fixation system, single-use
No Description
Bonebridge AG
B-240100
In Commercial Distribution

  • 07640187462173 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Acuitive Technologies, Inc.
30-103-0933
In Commercial Distribution

  • 00810027270634 ()
30-103-0933

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-103-0928
In Commercial Distribution

  • 00810027270627 ()
30-103-0928

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-103-0923
In Commercial Distribution

  • 00810027270610 ()
30-103-0923

  • Tendon/ligament bone anchor, bioabsorbable
No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Infant 9 - 15 cm
In Commercial Distribution

  • EMIP51000380 ()
5100038

  • Blood pressure cuff, reusable
No Description
ALIMED, INC.
154
In Commercial Distribution

  • 00733657218336 ()
2970000257

  • Wheelchair seat cushion
No Description
ALIMED, INC.
936983
In Commercial Distribution

  • 00733657240887 ()
2970014656

  • Freestanding patient positioner, reusable
No Description
ALIMED, INC.
936923
In Commercial Distribution

  • 00733657240788 ()
2970014618

  • Freestanding patient positioner, reusable
Diamond dental bur, reusable
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
191492
Not in Commercial Distribution

  • 07540172002844 ()
191492

  • Diamond dental bur, reusable
No Description
HIOSSEN, INC.
TRYHYD09
In Commercial Distribution

  • 00810126041951 ()


  • Dental implant suprastructure, temporary, preformed, single-use
No Description
CAPTIVA SPINE, INC.
14307-0910
In Commercial Distribution

  • M7391430709100 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FCI0910P
In Commercial Distribution

  • M739FCI0910P0 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FCI0910L
In Commercial Distribution

  • M739FCI0910L0 ()


  • Spinal implant trial
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Fenestrated model – made for voice prosthesis users. Can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7432
In Commercial Distribution

  • 07331791013737 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7432

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard model – made for use with or without a voice prosthesis. Can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7414
In Commercial Distribution

  • 07331791013713 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7414

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Fenestrated model – made for voice prosthesis users. Can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7431
In Commercial Distribution

  • 07331791013706 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7431

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard model – made for use with or without a voice prosthesis. Can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7413
In Commercial Distribution

  • 07331791013683 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7413

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard model – made for use with or without a voice prosthesis. Can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7412
In Commercial Distribution

  • 07331791013676 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 27 Millimeter
7412

  • Tracheostomy tube, non-reinforced, non-customized, reusable
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 model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users.
Atos Medical AB
7627
In Commercial Distribution

  • 07331791002373 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7627

  • Tracheostomy tube, non-reinforced, non-customized, reusable
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 model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users.
Atos Medical AB
7626
In Commercial Distribution

  • 07331791002359 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7626

  • Tracheostomy tube, non-reinforced, non-customized, reusable
No Description
Berman Instruments LLC
RAIN09
Not in Commercial Distribution

  • 00810060723180 ()


  • Rubber dam clamp
Avex CX2.022 UR2 (+10°T 9°A)
ULTRADENT PRODUCTS, INC.
524006
In Commercial Distribution

  • 00883205015747 ()
524006

  • Orthodontic bracket, ceramic
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