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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Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3209
In Commercial Distribution

  • 00810117210021 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A1946
In Commercial Distribution

  • 00810117210014 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3239-1
In Commercial Distribution

  • 00810117210090 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3239
In Commercial Distribution

  • 00810117210076 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3241
In Commercial Distribution

  • 00810117210069 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-010
In Commercial Distribution

  • 00810117210052 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3224-050
In Commercial Distribution

  • 00810117210045 ()


  • Nuclear medicine phantom, point source
Quality Assurance Point Source
Eckert & Ziegler Isotope Products, Inc.
A3209-2
In Commercial Distribution

  • 00810117210038 ()


  • Nuclear medicine phantom, point source
No Description
SUN NUCLEAR CORP.
TMM
In Commercial Distribution

  • B136411LE0 ()


  • Diagnostic ultrasound phantom, test object
No Description
SUN NUCLEAR CORP.
403GSLE
In Commercial Distribution

  • B136403GSLE0 ()


  • Diagnostic ultrasound phantom, test object
DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.
DIAGNOSTIC GRIFOLS SA
210700
In Commercial Distribution

  • 08437014205619 ()
210700

  • Agglutination assay digital imaging reader/analyser IVD
The DG Reader is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards. The instruments also identifies DG Gel 8 cards by Reading their barcodes. As a stand-alone instrument or interfaced to the customer's Laboratory Information System (LIS), the DG Reader automates data management requirements using DG Gel 8 cards and digital image processing.
DIAGNOSTIC GRIFOLS SA
213779
Not in Commercial Distribution

  • 08437014205176 ()
213779

  • Agglutination assay digital imaging reader/analyser IVD
ORTHO Optix™ Reader ID-MTS Gel
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842222
In Commercial Distribution

  • 10758750032846 ()
6842222

  • Agglutination assay digital imaging reader/analyser IVD
No Description
BIOMET SPINE LLC
14-500500
In Commercial Distribution

  • 00888480500766 ()

  • 5.5 MIS HF TI SET SCREW
14-500500

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6594MP
In Commercial Distribution

  • 00888480342090 ()

  • 5.0 X 40MM HF SEAT ASSY
50-6594MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6593MP
In Commercial Distribution

  • 00888480342083 ()

  • 5.0 X 35MM HF SEAT ASSY
50-6593MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6592MP
In Commercial Distribution

  • 00888480342076 ()

  • 5.0 X 30MM HF SEAT ASSY
50-6592MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6591MP
In Commercial Distribution

  • 00888480342069 ()

  • 5.0 X 25MM HF SEAT ASSY
50-6591MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
14-500500
In Commercial Distribution

  • 00880304973879 ()

  • 5.5 MIS HF TI SET SCREW
14-500500

  • Bone-screw internal spinal fixation system, non-sterile
HF SUCT./IRRIG. TUBE Ø 5.2MM WL 317MM for use with suction irrigation handle 8385.901, insulated with integrated HF hook electrode, with monopolar HF connection, capacity 3.7mm, reusable
Richard Wolf GmbH
8383812
Not in Commercial Distribution

  • 04055207015162 ()

  • Outer Diameter: 5.2 Millimeter
  • Length: 317 Millimeter
8383.812

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HF SUCT./IRRIG. TUBE Ø 5.2MM WL 317MM for use with suction irrigation handle 8385.901, insulated with integrated HF spatula probe, with monopolar HF connection, capacity 3.7mm, reusable
Richard Wolf GmbH
8383811
Not in Commercial Distribution

  • 04055207015155 ()

  • Outer Diameter: 5.2 Millimeter
  • Length: 317 Millimeter
8383.811

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object
HF SUCTION TUBE TEM Ø 5.6MM WL 305MM curved, integrated HF-electrode, with monopolar HF connection, capacity 3mm, reusable
Richard Wolf GmbH
8840731
In Commercial Distribution

  • 04055207021026 ()

  • Length: 305 Millimeter
  • Outer Diameter: 5.6 Millimeter
8840.731

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HF KNIFE Ø 4.5MM WL 433MM left-handed, curved, with ceramic insulation, with monopolar HF connection, TL 486mm, reusable
Richard Wolf GmbH
8840712
In Commercial Distribution

  • 04055207021019 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 433 Millimeter
8840.712

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HF KNIFE Ø 4.5MM WL 433MM right-handed, curved, with ceramic insulation, with monopolar HF connection, TL 486mm, reusable
Richard Wolf GmbH
8840711
In Commercial Distribution

  • 04055207021002 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 433 Millimeter
8840.711

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
310.288 @DRL BIT, FOR MDLR H& SYS, QK CO
MEDLINE INDUSTRIES, INC.
310288RH
In Commercial Distribution

  • 10888277378049 ()
310288RH

  • Cannulated surgical drill bit, single-use
PRIMARY KNEE TIBIA BASE SZ 5+ CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP51
In Commercial Distribution

  • KWBONP51 ()
  • M684KWBONP511 ()
KWBONP51

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 5 CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP50
In Commercial Distribution

  • KWBONP50 ()
  • M684KWBONP501 ()
KWBONP50

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 4 CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP40
In Commercial Distribution

  • KWBONP40 ()
  • M684KWBONP401 ()
KWBONP40

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 3+ CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP31
In Commercial Distribution

  • KWBONP31 ()
  • M684KWBONP311 ()
KWBONP31

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 3 CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP30
In Commercial Distribution

  • KWBONP30 ()
  • M684KWBONP301 ()
KWBONP30

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 2+ CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP21
In Commercial Distribution

  • KWBONP21 ()
  • M684KWBONP211 ()
KWBONP21

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 2 CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP20
In Commercial Distribution

  • KWBONP20 ()
  • M684KWBONP201 ()
KWBONP20

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 1+ CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP11
In Commercial Distribution

  • KWBONP11 ()
  • M684KWBONP111 ()
KWBONP11

  • Uncoated knee tibia prosthesis, metallic
PRIMARY KNEE TIBIA BASE SZ 1 CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP10
In Commercial Distribution

  • KWBONP10 ()
  • M684KWBONP101 ()
KWBONP10

  • Uncoated knee tibia prosthesis, metallic
3-LD Set, SNAP to TWIN, A, 29", TEL CO
CURBELL MEDICAL PRODUCTS, INC.
LW-2300029/3AT
Not in Commercial Distribution

  • 00840828148658 ()
9208

  • Electrocardiographic lead set, reusable
KANGAROO MOUNTING CLAMP FOR CO NSOLE WITH IRIS TECHNOLOGY
Cardinal Health 200, LLC
388104
In Commercial Distribution

  • 10192253007367 ()
388104

  • Frame/rail/pole device holder
CO connection cord Bath probe and inline sensor methods
NIHON KOHDEN CORPORATION
JT-950P
In Commercial Distribution

  • 04931921839805 ()
JT-950P

  • General-purpose multi-parameter bedside monitor
Adult Oral/Nasal CO Sampling Cannula for CapnoFlex Module
AIRLIFE
2013067-001
In Commercial Distribution

  • 50190752110616 ()
  • 10190752110618 ()
  • 10885403253171 ()
2013067-001

  • Nasal oxygen cannula, carbon-dioxide-sampling
***DISC*JUXTALITE HD 33 CM LL (XXL) W CO
MEDI MANUFACTURING, INC.
33037017
Not in Commercial Distribution

  • 00636257002568 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (LFC) W CO
MEDI MANUFACTURING, INC.
33035117
Not in Commercial Distribution

  • 00636257002537 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (MFC) W CO
MEDI MANUFACTURING, INC.
33034117
Not in Commercial Distribution

  • 00636257002513 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 28 CM LL (XXL) W CO
MEDI MANUFACTURING, INC.
33027017
Not in Commercial Distribution

  • 00636257002483 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 28 CM LL (MFC) W CO
MEDI MANUFACTURING, INC.
33024117
Not in Commercial Distribution

  • 00636257002438 ()


  • Compression bandaging kit
CO connection cord Bath probe and inline sensor methods
NIHON KOHDEN AMERICA, INC.
JT-950P
In Commercial Distribution

  • 00841983102288 ()
JT-950P

  • General-purpose multi-parameter bedside monitor
DBD-CUFF, REUS, SM ADLT LNG, 1 TB, NO CO
MEDLINE INDUSTRIES, INC.
MDS9912LRE
In Commercial Distribution

  • 20888277653297 ()
  • 10888277653290 ()
MDS9912LRE

  • Blood pressure cuff, reusable
10DP ADM 3 NDLSS Y-SITES 4WAY STPCK T CO
BD Switzerland Sàrl
MX4462
Not in Commercial Distribution

  • 10885403223006 ()
  • 50885403223004 ()
MX4462

  • Basic intravenous administration set, noninvasive
Co Ease Cohesive Bandage 3" x 5 yds. TAN
Hemasource, Inc.
CE30
In Commercial Distribution

  • 10857425005601 ()
  • 00857425005604 ()
  • 20857425005608 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 4" x 5 yds. TAN
Hemasource, Inc.
CE40C
In Commercial Distribution

  • 10857425005359 ()
  • 00857425005352 ()
  • 20857425005356 ()


  • Non-adhesive device retention bandage
Personal Use Kit OC-Auto, for CO Sprngs Hlth Prtnrs
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-CSHP
In Commercial Distribution

  • 00816917023106 ()


  • Faecal occult blood IVD, reagent
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