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
Biomet Orthopedics, LLC
1312-18-702
In Commercial Distribution

  • 00887868532139 ()

  • Small 9 Hole 88 mm
131218702

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
BIOMET SPINE LLC
83488E
In Commercial Distribution

  • 00880304986381 ()

  • FOUR LEVEL 88 MM PLATE
83488E

  • Bone-screw internal spinal fixation system, sterile
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
105-011385-00
In Commercial Distribution

  • 06944904084985 ()


  • Multiple electrolyte IVD, calibrator
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
105-011384-00
In Commercial Distribution

  • 06944904084978 ()


  • Multiple electrolyte IVD, calibrator
No Description
Heine Optotechnik GmbH & Co. KG
90 mm
In Commercial Distribution

  • 04053755131457 ()
G-000.21.342

  • Ear speculum, reusable
No Description
Heine Optotechnik GmbH & Co. KG
90 mm
In Commercial Distribution

  • 04053755131433 ()
G-000.21.332

  • Ear speculum, reusable
Surgical mallet - SPII Model Lubinus Hip Stem
WALDEMAR LINK GmbH & Co. KG
130-163/90
In Commercial Distribution

  • 04026575414659 ()


  • Surgical mallet
Orthopaedic prosthesis implantation instrument, reusable - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-042/90
In Commercial Distribution

  • 04026575315680 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Orthopaedic prosthesis implantation instrument, reusable - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-258/90
In Commercial Distribution

  • 04026575313198 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-151/90
In Commercial Distribution

  • 04026575306091 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-105/90
In Commercial Distribution

  • 04026575304820 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-150/90
In Commercial Distribution

  • 04026575302901 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-121/90
In Commercial Distribution

  • 04026575294268 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-120/90
In Commercial Distribution

  • 04026575289615 ()


  • Knee femur prosthesis trial, reusable
Knee tibia prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-285/90
In Commercial Distribution

  • 04026575312795 ()


  • Knee tibia prosthesis trial, reusable
Knee tibia prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-283/90
In Commercial Distribution

  • 04026575312610 ()


  • Knee tibia prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-130/90
In Commercial Distribution

  • 04026575184026 ()


  • Knee femur prosthesis trial, reusable
Knee femur prosthesis trial - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-131/90
In Commercial Distribution

  • 04026575082186 ()


  • Knee femur prosthesis trial, reusable
No Description
CHISON Medical Technologies Co., Ltd.
XBit 90
In Commercial Distribution

  • 06945121413480 ()
  • 06945121413459 ()
  • 06945121413619 ()
  • 06945121413633 ()
  • 06945121413732 ()
  • 06945121413749 ()
  • 06945121413756 ()
  • 06945121414043 ()
  • 06945121414050 ()
  • 06945121414104 ()
  • 06945121414067 ()
  • 06945121414111 ()
  • 06945121414074 ()
  • 06945121414128 ()
  • 06945121414081 ()
  • 06945121414098 ()
  • 06945121414142 ()
  • 06945121414203 ()
  • 06945121414708 ()
  • 06945121415569 ()


  • General-purpose ultrasound imaging system
No Description
Weihai Kangzheng Medical Equipment Technology Co., Ltd
3T
In Commercial Distribution

  • 06971257037177 ()


  • Multiple urine analyte IVD, control
Orion Trial Neck, High Offset, Size 10-12 (Version or Model Number) Has changed to the catalog number.
ORTHOMEDFLEX LLC
10122210
In Commercial Distribution

  • M716101222100 ()
101-222-10

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 4-5 (Version or Model Number) Has changed to the catalog number.
ORTHOMEDFLEX LLC
10122204
In Commercial Distribution

  • M716101222040 ()
101-222-04

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 6-7 (Version of Model Number) Has changed to the catalog number.
ORTHOMEDFLEX LLC
10122206
In Commercial Distribution

  • M716101222060 ()
101-222-06

  • Femoral stem prosthesis trial
RAN-823-CT, F/G, Sterile Part Number: 74315-02M
RANFAC CORP.
8GA X 23CM
In Commercial Distribution

  • 20857878007518 ()
  • 10857878007511 ()
  • 00857878007514 ()

  • Needle Gauge: 8 Gauge
  • Length: 23 Centimeter
RAN-823-CT

  • Bone access cannula
RAN-823-OT, F/G, Sterile Part Number 74315-01M
RANFAC CORP.
8GA X 23CM
In Commercial Distribution

  • 20857878007501 ()
  • 10857878007504 ()
  • 00857878007507 ()

  • Needle Gauge: 8 Gauge
  • Length: 23 Centimeter
RAN-823-OT

  • Bone access cannula
Low Torque T-Handle (Distributor Part Number 254600410)
GAUTHIER BIOMEDICAL, INC.
254600410
In Commercial Distribution

  • 00858325005169 ()
G140553

  • Surgical instrument handle, torque-limiting
Male Enhancement Pump System Part Number: BL-09037
Blush Novelties
PERFORMANCE VX5
In Commercial Distribution

  • 00853858007222 ()
BL-09037

  • Penile vacuum device
Orthex SB Number Clip #5 DARK BLUE
VILEX IN TENNESSEE, INC.
CS-12-5
In Commercial Distribution

  • 00841731123404 ()


  • External orthopaedic fixation system, single-use
Armrest, EU GE Part Number: 5405554 007
HILL-ROM, INC.
112004
In Commercial Distribution

  • 00615521015541 ()
GE5405554

  • Arm procedure positioner, reusable
Armboard, US GE Part Number: 5402058 006
HILL-ROM, INC.
112004
In Commercial Distribution

  • 00615521015435 ()
GE5402058

  • Arm procedure positioner, reusable
Stylet for 100mm Catheter, model number Type6-v2
KITAZATO CORPORATION
140198 Type6-v2
In Commercial Distribution

  • 14580303269289 ()
  • 04580303269282 ()
140198

  • Assisted reproduction transfer catheter/set
Stylet for 180mm Catheter, model number Type6-v1
KITAZATO CORPORATION
140118 Type6-v1
In Commercial Distribution

  • 14580303269272 ()
  • 04580303269275 ()
140118

  • Assisted reproduction transfer catheter/set
for "handle, double ended" (item number 20-804-00)
Spiggle & Theis Medizintechnik GmbH
20-804-99
In Commercial Distribution

  • 04250676701237 ()
20-804-99

  • Nasal file/rasp
Re-order number 5808PV. Supplied 6 per case.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5808PV-1
In Commercial Distribution

  • 20842430101773 ()
  • 00842430101779 ()
  • 10842430101776 ()
5808PV

  • Surgical linen/cushion set
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2
DEPUY SPINE, LLC
292900550
In Commercial Distribution

  • 10705034225302 ()
292900550

  • Instrument tray, reusable
SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1
Medos International Sàrl
292900500
In Commercial Distribution

  • 10705034225272 ()
292900500

  • Surgical instrument/implant rack
NUMBER LABEL SET FOR MODULAR SCREW CADDY
ORTHOPEDIATRICS CORP.
01-0099-0003
In Commercial Distribution

  • 00841132130285 ()
01-0099-0003

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Part Number 102100 VTI Oxygen Analyzer/Monitor
VASCULAR TECHNOLOGY, INCORPORATED
102100
Not in Commercial Distribution

  • 00817122020072 ()
102100

  • Respiratory oxygen monitor, battery-powered
Matched Number 100mL in 4mL, Glass Tip
CADENCE SCIENCE, INC.
5179
Not in Commercial Distribution

  • 00816329021790 ()
5179

  • General-purpose syringe, reusable
Matched Number 100mL in 4mL, Lock Tip
CADENCE SCIENCE, INC.
5177
Not in Commercial Distribution

  • 00816329021776 ()
5177

  • General-purpose syringe, reusable
Matched Number 50mL in 2mL, Glass Tip
CADENCE SCIENCE, INC.
5159
Not in Commercial Distribution

  • 00816329021592 ()
5159

  • General-purpose syringe, reusable
Matched Number 50mL in 2mL, Lock Tip
CADENCE SCIENCE, INC.
5157
Not in Commercial Distribution

  • 00816329021578 ()
5157

  • General-purpose syringe, reusable
Matched Number 30mL in 1mL, Glass Tip
CADENCE SCIENCE, INC.
5149
Not in Commercial Distribution

  • 00816329021493 ()
5149

  • General-purpose syringe, reusable
Matched Number 30mL in 1mL, Lock Tip
CADENCE SCIENCE, INC.
5147
Not in Commercial Distribution

  • 00816329021479 ()
5147

  • General-purpose syringe, reusable
Matched Number 20mL in 1mL, Glass Tip
CADENCE SCIENCE, INC.
5139
Not in Commercial Distribution

  • 00816329021394 ()
5139

  • General-purpose syringe, reusable
Matched Number 20mL in 1mL, Metal Tip
CADENCE SCIENCE, INC.
5138
Not in Commercial Distribution

  • 00816329021387 ()
5138

  • General-purpose syringe, reusable
Matched Number 20mL in 1mL, Lock Tip
CADENCE SCIENCE, INC.
5137
Not in Commercial Distribution

  • 00816329021370 ()
5137

  • General-purpose syringe, reusable
Matched Number 250mL in 10mL, Lock Tip
CADENCE SCIENCE, INC.
5333
Not in Commercial Distribution

  • 00816329023336 ()
5333

  • General-purpose syringe, reusable
Matched Number 150mL in 10mL, Lock Tip
CADENCE SCIENCE, INC.
5331
Not in Commercial Distribution

  • 00816329023312 ()
5331

  • General-purpose syringe, reusable
S-ROM NOILES PATELLAR INSTRUMENTS - CASE Number 7
DEPUY ORTHOPAEDICS, INC.
60-1030
In Commercial Distribution

  • 10603295178286 ()
601030

  • Instrument tray, reusable
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