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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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MONOAXIAL REDUCTION SCREW
Stryker Corporation
481305535
In Commercial Distribution

  • 07613252093244 ()

  • Length: 35.0 Millimeter
  • Diameter: 5.5 Millimeter
481305535

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481305530
In Commercial Distribution

  • 07613252093237 ()

  • Length: 30.0 Millimeter
  • Diameter: 5.5 Millimeter
481305530

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481305525
In Commercial Distribution

  • 07613252093220 ()

  • Diameter: 5.5 Millimeter
  • Length: 25.0 Millimeter
481305525

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481305520
In Commercial Distribution

  • 07613252093213 ()

  • Diameter: 5.5 Millimeter
  • Length: 20.0 Millimeter
481305520

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481304540
In Commercial Distribution

  • 07613252093190 ()

  • Length: 40.0 Millimeter
  • Diameter: 4.5 Millimeter
481304540

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481304530
In Commercial Distribution

  • 07613252093176 ()

  • Length: 30.0 Millimeter
  • Diameter: 4.5 Millimeter
481304530

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481304525
In Commercial Distribution

  • 07613252093169 ()

  • Diameter: 4.5 Millimeter
  • Length: 25.0 Millimeter
481304525

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL REDUCTION SCREW
Stryker Corporation
481304520
In Commercial Distribution

  • 07613252093152 ()

  • Diameter: 4.5 Millimeter
  • Length: 20.0 Millimeter
481304520

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48137570
In Commercial Distribution

  • 07613154991853 ()

  • Length: 70.0 Millimeter
  • Diameter: 7.5 Millimeter
48137570

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48137555
In Commercial Distribution

  • 07613154991839 ()

  • Length: 55.0 Millimeter
  • Diameter: 7.5 Millimeter
48137555

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48137060
In Commercial Distribution

  • 07613154991570 ()

  • Length: 60.0 Millimeter
  • Diameter: 7.0 Millimeter
48137060

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48135570
In Commercial Distribution

  • 07613154991549 ()

  • Diameter: 5.5 Millimeter
  • Length: 70.0 Millimeter
48135570

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48135560
In Commercial Distribution

  • 07613154991532 ()

  • Diameter: 5.5 Millimeter
  • Length: 60.0 Millimeter
48135560

  • Spinal bone screw, non-bioabsorbable
MONOAXIAL SCREW
Stryker Corporation
48135080
In Commercial Distribution

  • 07613154991525 ()

  • Length: 80.0 Millimeter
  • Diameter: 5.0 Millimeter
48135080

  • Spinal bone screw, non-bioabsorbable
The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 5, see: http://www.omnitrope.com/getting-started/injection-training/
Sandoz GmbH
49036229
Not in Commercial Distribution

  • 49002269218553 ()
  • 59002269207349 ()


  • Empty self-injector, mechanical
5/16 WYE
Quality Aspirators, Inc.
5/16 WYE
In Commercial Distribution

  • 00814005024974 ()
313-10007

  • Dental suction system cannula, reusable
No Description
Biomet Orthopedics, LLC
29410
In Commercial Distribution

  • 00888480266105 ()
29410

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
ACCUTRON, INC.
34016
In Commercial Distribution

  • 00813830021813 ()
34016

  • Anaesthesia workstation gas scavenger
DrugSmart Cup 5, AMP/COC/OPI/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60565D
In Commercial Distribution

  • 00812203030124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Cytokeratin 5 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.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66020 ()
BSB 6602

  • Cytokeratin IVD, antibody
Cytokeratin 5 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.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66010 ()
BSB 6601

  • Cytokeratin IVD, antibody
Cytokeratin 5 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.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66000 ()
BSB 6600

  • Cytokeratin IVD, antibody
DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles).
Dong Bang Medical co.,Ltd.
dtx.22x13
In Commercial Distribution

  • 38800018900858 ()
  • 28800018900851 ()
  • 18800018900854 ()
  • 08800018900857 ()

  • 0.22 mm x 13 mm
dtx.22x13

  • Acupuncture needle, single-use
DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles).
Dong Bang Medical co.,Ltd.
dtx.20x13
In Commercial Distribution

  • 38800018900841 ()
  • 28800018900844 ()
  • 18800018900847 ()
  • 08800018900840 ()

  • 0.20 mm x 13 mm
dtx.20x13

  • Acupuncture needle, single-use
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7723
In Commercial Distribution

  • 07331791015854 ()
  • 07331791017100 ()
7723

  • Tracheostoma protective filter
No Description
BIOPRO, INC.
17309
In Commercial Distribution

  • 00810012485654 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTR12, 5x100 Kii OPT ZTHR DP 10/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK202
In Commercial Distribution

  • 20607915129143 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK318
In Commercial Distribution

  • 30607915135585 ()


  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Implant 4.1*5
DENTACK IMPLANTS LTD
EDI-4105
In Commercial Distribution

  • 07290112280664 ()


  • Screw endosteal dental implant, two-piece
No Description
Thought Technology Ltd.
SA7525
In Commercial Distribution

  • 07540191000043 ()


  • Psychophysiological biofeedback system
No Description
Trilliant Surgical, LLC
211-99-007
In Commercial Distribution

  • 00810028395169 ()


  • Orthopaedic bone screw (non-sliding)
Neuromuscular Electrical Stimulator intended for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
BIO-MEDICAL RESEARCH LIMITED
517 - US
In Commercial Distribution

  • 15099058517020 ()
0517-5010

  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Neuromuscular Electrical Stimulator intended for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
BIO-MEDICAL RESEARCH LIMITED
517 - US
In Commercial Distribution

  • 15099058517013 ()
0517-5012

  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BIOGENEX LABORATORIES
AN892-10M
In Commercial Distribution

  • 00810119678072 ()

  • Total Volume: 10 Milliliter
AN892-10M

  • Multiple squamous cell carcinoma-associated marker IVD, antibody
No Description
MANUKAMED LIMITED PARTNERSHIP
MM0070
In Commercial Distribution

  • 05060188821205 ()
  • 05060188821199 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial
Talymed dressing 5 cm x 5 cm
Marine Polymer Technologies, Inc.
400-20
In Commercial Distribution

  • 00389142000209 ()
  • 10389142000206 ()


  • Wound regenerating polysaccharide agent
mrdh bandage 5 cm x 5 cm (2 "x 2")
Marine Polymer Technologies, Inc.
400-25
In Commercial Distribution

  • 10389142000121 ()
  • 00389142000124 ()


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
5 LD WELCH ALLYN MICROPAQ 5 'CABLE
CURBELL MEDICAL PRODUCTS, INC.
CB-72521R-5
In Commercial Distribution

  • 00840828149945 ()
5524

  • Electrocardiographic electrode connector
No Description
Roche Diagnostics GmbH
05915759190
In Commercial Distribution

  • 04015630942688 ()
05915759190

  • Troponin T/Troponin I IVD, control
Kit 5 Orange (System 5 Kit)
MEDSOURCE INTERNATIONAL LLC
MS-MED5O
In Commercial Distribution

  • 00816703021880 ()


  • Patient monitoring system module, blood pressure, noninvasive
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