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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EXTERNAL TRACKER FIXATOR, 0° ATTACHMENT
Exactech, Inc.
521-10-00
In Commercial Distribution

  • 10885862092779 ()
521-10-00

  • Orthopaedic stereotactic surgery system
Oculocam external digital camera mount.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8100DCEX
In Commercial Distribution

  • B1778100DCEX0 ()


  • Surgical camera holder
Cryptococcus Antigen External Positive Control
Immuno-Mycologics, Inc.
CB0050
In Commercial Distribution

  • 00816387020261 ()


  • Cryptococcus neoformans antigen IVD, control
Gait-enhancement electrical stimulation system, external
AXIOBIONICS
0
In Commercial Distribution

  • B3677500 ()
75

  • Transcutaneous electrical stimulation electrode, single-use
EXTERNAL COLLECTOR,FECAL MANAGEMENT,40EA
MEDLINE INDUSTRIES, INC.
FMEX01
In Commercial Distribution

  • 10888277728929 ()
  • 20888277728926 ()
  • 00888277728922 ()
FMEX01

  • Faecal incontinence collector, catheterization
Integra® External Drainage System
Integra Lifesciences Corporation
NL8508601
In Commercial Distribution

  • 10381780071709 ()
  • M269NL85086011 ()

  • 700ml drainage bag, 50ml vented burette
NL8508601

  • Ventricular cerebrospinal fluid drainage catheterization kit
Integra® External Drainage System
Integra Lifesciences Corporation
NL8508600
In Commercial Distribution

  • 10381780071693 ()
  • M269NL85086001 ()

  • 700ml drainage bag, 50ml vented burette
NL8508600

  • Ventricular cerebrospinal fluid drainage catheterization kit
Screw for Internal External Abut'
DENTIN IMPLANTS TECHNOLOGIES LTD
SCIE-2510
In Commercial Distribution

  • 07290113354265 ()


  • Dental prosthesis/implant abutment screw
Screw for Internal External Abut'
DENTIN IMPLANTS TECHNOLOGIES LTD
TWA-1302
In Commercial Distribution

  • 07290113354791 ()


  • Dental prosthesis/implant abutment screw
Short Drill ø5.50mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144434 ()
TD1-0018

  • Dental implant system
Short Drill ø5mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144427 ()
TD1-0017

  • Dental implant system
Short Drill ø4.50mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144410 ()
TD1-0016

  • Dental implant system
Short Drill ø3.80mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144403 ()
TD1-0015

  • Dental implant system
Short Drill ø3.20mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144397 ()
TD1-0014

  • Dental implant system
Short Drill ø2.80mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144380 ()
TD1-0013

  • Dental implant system
Short Drill ø2.50mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144373 ()
TD1-0012

  • Dental implant system
Pilot Drill ø2mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144281 ()
TD1-0003

  • Dental implant system
Hand Piece external hygienic CO2RE
SYNERON MEDICAL LTD
AS90245
Not in Commercial Distribution

  • 17290109952380 ()
  • 07290109952383 ()
AS90245

  • Dermatological carbon dioxide laser system
Integra® External Drainage System
Integra Lifesciences Corporation
NL8508600
In Commercial Distribution

NL8508600

  • Ventricular cerebrospinal fluid drainage catheterization kit
5-Pk, external hygienic, CO2RE Intima
Candela Corporation
KT76685
In Commercial Distribution

  • 00817495024400 ()
KT76685

  • Dermatological carbon dioxide laser system
NON-BRIDGING EXTERNAL FIXATOR HAND SHORT
NUTEK ORTHOPAEDICS INC
8307-00-00
In Commercial Distribution

  • B488830700000 ()
8307-00-00

  • External orthopaedic fixation system, single-use, sterile
NON-BRIDGING EXTERNAL FIXATOR HAND LONG
NUTEK ORTHOPAEDICS INC
8207-00-00
In Commercial Distribution

  • B488820700000 ()
8207-00-00

  • External orthopaedic fixation system, single-use, sterile
External Stain VC Glaze 10g
KURARAY NORITAKE DENTAL INC.
104-5581KA
In Commercial Distribution

  • EKUR1045581KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain FL Glaze 10g
KURARAY NORITAKE DENTAL INC.
104-5571KA
In Commercial Distribution

  • EKUR1045571KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Salmon Pink 3g
KURARAY NORITAKE DENTAL INC.
104-3611KA
In Commercial Distribution

  • EKUR1043611KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Reddish Brown 3g
KURARAY NORITAKE DENTAL INC.
104-3601KA
In Commercial Distribution

  • EKUR1043601KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Earth Brown 3g
KURARAY NORITAKE DENTAL INC.
104-3591KA
In Commercial Distribution

  • EKUR1043591KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Pure White 3g
KURARAY NORITAKE DENTAL INC.
104-3481KA
In Commercial Distribution

  • EKUR1043481KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Salmon Pink 3g
KURARAY NORITAKE DENTAL INC.
103-1441KA
In Commercial Distribution

  • EKUR1031441KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Reddish Brown 3g
KURARAY NORITAKE DENTAL INC.
103-1431KA
In Commercial Distribution

  • EKUR1031431KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Earth Brown 3g
KURARAY NORITAKE DENTAL INC.
103-1421KA
In Commercial Distribution

  • EKUR1031421KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Pure White 3g
KURARAY NORITAKE DENTAL INC.
103-1311KA
In Commercial Distribution

  • EKUR1031311KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Salmon Pink 3g
KURARAY NORITAKE DENTAL INC.
102-3591KA
In Commercial Distribution

  • EKUR1023591KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Reddish Brown 3g
KURARAY NORITAKE DENTAL INC.
102-3581KA
In Commercial Distribution

  • EKUR1023581KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Earth Brown 3g
KURARAY NORITAKE DENTAL INC.
102-3571KA
In Commercial Distribution

  • EKUR1023571KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Pure White 3g
KURARAY NORITAKE DENTAL INC.
102-3461KA
In Commercial Distribution

  • EKUR1023461KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Reddish Brown 3g
KURARAY NORITAKE DENTAL INC.
108-1721KA
In Commercial Distribution

  • EKUR1081721KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical 3 3g
KURARAY NORITAKE DENTAL INC.
108-1701KA
In Commercial Distribution

  • EKUR1081701KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical 1 3g
KURARAY NORITAKE DENTAL INC.
108-1681KA
In Commercial Distribution

  • EKUR1081681KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange 2 3g
KURARAY NORITAKE DENTAL INC.
108-1661KA
In Commercial Distribution

  • EKUR1081661KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green 2 3g
KURARAY NORITAKE DENTAL INC.
108-1641KA
In Commercial Distribution

  • EKUR1081641KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green 1 3g
KURARAY NORITAKE DENTAL INC.
107-1481KA
In Commercial Distribution

  • EKUR1071481KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Salmon Pink 3g
KURARAY NORITAKE DENTAL INC.
108-1731KA
In Commercial Distribution

  • EKUR1081731KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Earth Brown 3g
KURARAY NORITAKE DENTAL INC.
108-1711KA
In Commercial Distribution

  • EKUR1081711KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Cervical 2 3g
KURARAY NORITAKE DENTAL INC.
108-1691KA
In Commercial Distribution

  • EKUR1081691KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Orange 1 3g
KURARAY NORITAKE DENTAL INC.
108-1651KA
In Commercial Distribution

  • EKUR1081651KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Green 1 3g
KURARAY NORITAKE DENTAL INC.
108-1631KA
In Commercial Distribution

  • EKUR1081631KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Pure White 3g
KURARAY NORITAKE DENTAL INC.
108-1601KA
In Commercial Distribution

  • EKUR1081601KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Salmon Pink 3g
KURARAY NORITAKE DENTAL INC.
107-1581KA
In Commercial Distribution

  • EKUR1071581KA0 ()


  • Dental appliance fabrication material, ceramic
External Stain Reddish Brown 3g
KURARAY NORITAKE DENTAL INC.
107-1571KA
In Commercial Distribution

  • EKUR1071571KA0 ()


  • Dental appliance fabrication material, ceramic
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