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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5mL/bottle. Concentration: 1000 ng/mL of Oxazepam.
LIN-ZHI INTERNATIONAL, INC.
0135
In Commercial Distribution

  • B07601350 ()
0135

  • Benzodiazepine group IVD, calibrator
5/45 Angled Jewelers forceps (5 mm long at 45 degree angle)
Cole Instruments Inc
5/45 Angled Jewelers forceps
In Commercial Distribution

  • 00810072350848 ()
371.002

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
5" Pad for Trigger Lite Armboard.
COMPOSITE MANUFACTURING, INC.
2-010-10-5WS
In Commercial Distribution

  • 00810105030624 ()


  • Arm procedure positioner, reusable
No Description
HIOSSEN, INC.
FNLHYD05
In Commercial Distribution

  • 00810126042019 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Dual Socket Leadwire Set of 5: Socket to Pinch (Blk, Red, Brn, Grn, Wht), Various Lengths
MERIT CABLES INCORPORATED
60300-X-5A
In Commercial Distribution

  • 90817266020764 ()

  • Length: 40 Inch
  • Length: 30 Inch
  • Length: 24 Inch


  • Electrocardiographic lead set, reusable
No Description
Trilliant Surgical, LLC
300-50-005
In Commercial Distribution

  • 00812926022468 ()

  • 5 Hole VLC Gridlock Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Trilliant Surgical, LLC
210-24-004
In Commercial Distribution

  • 00812926021409 ()

  • 0.035" x 5" K-Wire Standard


  • Orthopaedic bone wire
Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control
Tilt-Only Angled Back canes (pair). Back Canes are designed with a 5° angle bend. (Cane height/length options= 20H, 22H, 24H). Wheelchair components for use on on Motion Concepts Power Positioning Systems with Tilt.
Motion Concepts Inc
D-0124-ABC
In Commercial Distribution

  • 07540147001605 ()
ABC

  • Wheelchair bracket/mount
No Description
Berman Instruments LLC
GC045
Not in Commercial Distribution

  • 00810060722848 ()


  • Dental restoration carver, resin
The Ammonia Standards are intended for the calibration of ammonia assays.
POINTE SCIENTIFIC, INC.
A7553-STD500
In Commercial Distribution

  • 00811727010278 ()
A7553-STD500

  • Ammonia IVD, calibrator
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014326 ()
CDR-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014302 ()
CABC-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
54319-61
In Commercial Distribution

  • 10810929045146 ()
  • 00810929045149 ()


  • Medical device cleaning agent
MUELLER HINTON w 5% SB
Healthlink
1107
In Commercial Distribution

  • M20211072 ()
  • M20211071 ()
  • M20211070 ()

  • Outer Diameter: 150 Millimeter
  • 150 mm
1107

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
MUELLER HINTON w 5% SB
Healthlink
1104
In Commercial Distribution

  • M20211042 ()
  • M20211041 ()
  • M20211040 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
1104

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
Freevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma
Atos Medical AB
7789
In Commercial Distribution

  • 07331791016578 ()
  • 07331791008979 ()
7789

  • Tracheostoma protective filter
Freevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma
Atos Medical AB
7788
In Commercial Distribution

  • 07331791016561 ()
  • 07331791008962 ()
7788

  • Tracheostoma protective filter
Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
Atos Medical AB
7247
In Commercial Distribution

  • 07331791001550 ()
  • 07331791010590 ()
  • 07331791017766 ()
7247

  • Tracheostoma protective filter
No Description
Maquet Critical Care AB
6887050
In Commercial Distribution

  • 07325710009796 ()


  • Neonatal/adult intensive-care ventilator
No Description
Maquet Critical Care AB
6694267
Not in Commercial Distribution

  • 17325710001995 ()
  • 07325710001998 ()


  • Anaesthesia face mask, single-use
No Description
Acuitive Technologies, Inc.
30-102-0515
In Commercial Distribution

  • 00810027270207 ()
30-102-0515

  • Tendon/ligament bone anchor, bioabsorbable
No Description
Acuitive Technologies, Inc.
30-102-0510
In Commercial Distribution

  • 00810027270191 ()
30-102-0510

  • Tendon/ligament bone anchor, bioabsorbable
URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-antibody-purified-10956
BIOLEGEND, INC.
905501
In Commercial Distribution

  • 00810034700063 ()

  • Total Volume: 100 Microliter
905501

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort port (e.g., Vial Adaptor) The device Proximal end is intended to connect to luer syringe
SIMPLIVIA HEALTHCARE LTD
412188
In Commercial Distribution

  • 37290115921886 ()
  • 27290115921889 ()
  • 17290115921882 ()


  • Medication transfer set
Actuated Holder
MIZUHO AMERICA, INC.
07-863-05
In Commercial Distribution

  • 00810009463511 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
CS5+,110V ENG, LN02005-110-EP
HAEMONETICS CORPORATION
02005-110-EP
In Commercial Distribution

  • 30812747016814 ()


  • Autotransfusion system blood collection/processing pump
No Description
XODUS MEDICAL, INC.
20048
In Commercial Distribution

  • 00787551001051 ()
  • 10787551001058 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
No Description
XODUS MEDICAL, INC.
20018
In Commercial Distribution

  • 00787551000962 ()
  • 10787551000969 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
No Description
ADIN DENTAL IMPLANT SYSTEMS LTD
RS2655
In Commercial Distribution

  • 07290105154767 ()


  • Dental implant suprastructure, permanent, preformed
No Description
MAZOR ROBOTICS LTD
KIT0722-03
In Commercial Distribution

  • 07290109184418 ()


  • Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
KIT0722-02
In Commercial Distribution

  • 07290109183848 ()


  • Stereotactic surgery system probe, reusable
Cranial Drill Bit,5 pack
MAZOR ROBOTICS LTD
KIT0722-01
In Commercial Distribution

  • 07290109180625 ()


  • Muscle biopsy clamp
No Description
MAZOR ROBOTICS LTD
KIT0712-01
In Commercial Distribution

  • 07290109180571 ()


  • Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
KIT0710-01
In Commercial Distribution

  • 07290109180557 ()


  • Stereotactic surgery system probe, reusable
FLEXICOL SACRAL 6X7 5/BX
HARTMANN USA, INC.
48620000
In Commercial Distribution

  • 40612553013727 ()
  • 20612553013723 ()
  • 10612553024661 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Kit includes: CFB12, 5x100 Kii SH BLD ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm Inzii RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK121
In Commercial Distribution

  • 20607915126272 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
Wide Healing Cap L - 5, body width 5.5 mm
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742908 ()

  • Collar Height: 5
  • Width: 5.5 Millimeter
GIH-HCW5

  • Dental implant suprastructure, temporary, preformed, single-use
Straight Multi Unit L=5
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742144 ()

  • Length: 2 Millimeter
BH-MUOOH5

  • Dental implant suprastructure, permanent, preformed
MJ Electric - Assortment Pack #5
Certified Safety Manufacturing, Inc.
KR623-324
In Commercial Distribution

  • 00766588233246 ()
KR623-324

  • First aid kit, medicated
The Omni™ 5 Fr. Seal Caps are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of the removable outflow channels.
Hologic, Inc.
60-5FR
In Commercial Distribution

  • 15420045513839 ()
  • 45420045513847 ()
  • 35420045513840 ()
  • 25420045513843 ()
60-5FR

  • Endoscope working-channel seal
bubblr gum
PEARSON DENTAL SUPPLIES, INC.
M091000
In Commercial Distribution

  • D724M091001 ()


  • Dental cavity varnish solvent
Root canal post
RECHERCHES TECHNIQUES DENTAIRES
4590315B
In Commercial Distribution

  • ERTD4590315B012 ()
  • ERTD45900505BV001 ()
  • ERTDAE5ILLUSIONXRO000 ()
4590315B

  • Root canal post, preformed
Spotter Sensors - Package of 5
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Spotter Sensors - Package of 5
In Commercial Distribution

  • 17290114352304 ()


  • Magnetic metal detector
QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
SYNTRON BIORESEARCH, INC.
60505
In Commercial Distribution

  • 20748349000056 ()
  • 10748349000059 ()
  • 00748349000052 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Baby-Metzenbaum scissors,cvd.,5/330mm
mahe medical gmbh
26.208.33
In Commercial Distribution

  • EMAH26208330 ()
26.208.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Peritoneal scissors,serrated,5/330mm
mahe medical gmbh
26.204.33
In Commercial Distribution

  • EMAH26204330 ()
26.204.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Multiple teeth grasp.fcps.,5/330mm
mahe medical gmbh
26.092.33
In Commercial Distribution

  • EMAH26092330 ()
26.092.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Biopsy spoon fcps.,5/330mm
mahe medical gmbh
26.084.33
In Commercial Distribution

  • EMAH26084330 ()
26.084.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
McKearnan grasp.fcps.,fenestr.,5/330mm
mahe medical gmbh
26.043.33
In Commercial Distribution

  • EMAH26043330 ()
26.043.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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