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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High Density Insert Set for Catphan® 700
Providus Holdings, Inc.
CTP748
In Commercial Distribution

  • 00812266030284 ()
CTP748

  • CT phantom, test object
42-55cm oval OD 20cm thick uniformity material body annulus
Providus Holdings, Inc.
CTP750-20
In Commercial Distribution

  • 00812266030260 ()
CTP750-20

  • CT phantom, test object
Teflon annulus
Providus Holdings, Inc.
CTP299
In Commercial Distribution

  • 00812266030062 ()
CTP299

  • CT phantom, test object
Catphan® 700, Complete Catphan® including housing, case, and Smári Image Analysis Database Service.
Providus Holdings, Inc.
CTP700
In Commercial Distribution

  • 00812266030048 ()


  • CT phantom, test object
Catphan® 600, Complete Catphan® including housing, case, and Smári Image Analysis Database Service
Providus Holdings, Inc.
CTP600
In Commercial Distribution

  • 00812266030031 ()


  • CT phantom, test object
Catphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Service.
Providus Holdings, Inc.
CTP500
In Commercial Distribution

  • 00812266030024 ()


  • CT phantom, test object
COPDGene Lung Phantom ll
Providus Holdings, Inc.
CCT162
In Commercial Distribution

  • 00812266030017 ()


  • CT phantom, test object
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
468BHP
In Commercial Distribution

  • B136468BHP0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
468BH
In Commercial Distribution

  • B136468BH0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
467
In Commercial Distribution

  • B1364670 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
464
In Commercial Distribution

  • B1364640 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
2823
In Commercial Distribution

  • B13628230 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
200
In Commercial Distribution

  • B1362000 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
1472
In Commercial Distribution

  • B13614720 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
1467
In Commercial Distribution

  • B13614670 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
1464
In Commercial Distribution

  • B13614640 ()


  • CT phantom, test object
No Description
NEUROLOGICA CORP.
10-01527-001
Not in Commercial Distribution

  • 10815411020755 ()


  • CT phantom, test object
K-BALL
S.M.A.I.O
01BK0001
In Commercial Distribution

  • 03701313007942 ()
01BK0001

  • CT phantom, test object
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
lnclinometer wireless
In Commercial Distribution

  • EPTWT430360 ()
T43036

  • Bone densitometry ultrasound phantom, test object
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
DBD-CUFF, REUS, SM ADLT LNG, 1 TB, NO CO
MEDLINE INDUSTRIES, INC.
MDS9912LRE
In Commercial Distribution

  • 20888277653297 ()
  • 10888277653290 ()
MDS9912LRE

  • Blood pressure cuff, reusable
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 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 5+ CO / CR NONPOROUS
Microport Orthopedics Inc.
KWBONP51
In Commercial Distribution

  • KWBONP51 ()
  • M684KWBONP511 ()
KWBONP51

  • 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 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
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
***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
***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
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
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 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
Co Ease Cohesive Bandage 4" x 5 yds. BLACK
Hemasource, Inc.
CE40BK
In Commercial Distribution

  • 20891153001037 ()
  • 00891153001033 ()
  • 30891153001034 ()


  • 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
Table Top Rod Cutter, 4.5-5.0-5.5-6.0 Collapsible Co Cr, Purple
TECOMET INC.
RC305008-AF
In Commercial Distribution

  • 00818069018276 ()


  • Orthopaedic implantable-device cutter
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
MAGNUM SALDATURA CO - Stick Ø1.2x75mm RGH - 50g - Jar1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612201991 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA Co - Stick Ø1.7x75mm RGH - 5g - Box1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612203025 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA Co - Stick Ø1.7x75mm RGH - 50g - Box1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612202110 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA CO - Stick Ø1.7x75mm RGH - 50g - Jar1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612202004 ()


  • Dental casting non-noble alloy
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