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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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Pedicraft - 00766923182505

Bassinet with Drawer
PEDICRAFT, INC.
18250
In Commercial Distribution

  • 00766923182505 ()
18250

  • Neonatal bed

TetraSensitive - 07350012440244

TetraSensitive with EZconnect
Senzime AB (Publ.)
SEN 2016 TetraSensitive
In Commercial Distribution

  • 07350012440251 ()
  • 07350012440244 ()
SEN 2016

  • Block-monitoring peripheral nerve electrical stimulation system

TetraSens - 07350012440169

TetraSens with EZconnect
Senzime AB (Publ.)
SEN 2012 TetraSens
In Commercial Distribution

  • 07350012440176 ()
  • 07350012440169 ()
SEN 2012

  • Block-monitoring peripheral nerve electrical stimulation system

Etac Supply Center AB - 07320450085314

With support legs
Etac Supply Center AB
Optima 1
In Commercial Distribution

  • 07320450085314 ()
80303001

  • Toilet hand rail

Etac Supply Center AB - 07320450001659

With brackets, 10cm
Etac Supply Center AB
Hi-Loo
In Commercial Distribution

  • 07320450001659 ()
80301105

  • Raised toilet seat

Vivo Series - 07321820051205

T-piece with plug
Breas Medical AB
005120
In Commercial Distribution

  • 07321820051205 ()
005120

  • Ventilator breathing circuit, reusable

Hahnenkratt - E206120

Ivory with shields
E. Hahnenkratt GmbH
12
In Commercial Distribution

  • E206120 ()


  • Dental matrix band tensioner

Flexible Implant Tubes - 08717213010024

Obturator With Bevelpoint
Nucletron B.V.
089024
In Commercial Distribution

  • 08717213010024 ()


  • General-purpose brachytherapy system applicator, remote-afterloading

Flexible Implant Tubes - 08717213010000

Obturator With Trocarpoint
Nucletron B.V.
089022
In Commercial Distribution

  • 08717213010000 ()


  • General-purpose brachytherapy system applicator, remote-afterloading

Dr. Brown's - 00072239321300

Gripebelt with teether
Dr. Brown's Company
HG104
In Commercial Distribution

  • 00072239321300 ()


  • Hot/cold therapy pack, reusable
  • Infant care kit

Dr. Brown's - 00072239321294

Gripebelt with teether
Dr. Brown's Company
HG103
In Commercial Distribution

  • 00072239321294 ()


  • Hot/cold therapy pack, reusable
  • Infant care kit

Cook - 00827002070097

Dilator with Handle
COOK INCORPORATED
G07009
Not in Commercial Distribution

  • 00827002070097 ()
JCD18.0-38-13.3-H-TCCS

  • Fascial tissue dilator, single-use

NA - 10705034708768

CHUCK WITH T-HANDLE
Synthes GmbH
SD393.100
In Commercial Distribution

  • H981SD3931000 ()
  • 10705034708768 ()
SD393100

  • Surgical drill chuck

NA - 10705034706238

AWL WITH T-HANDLE
Synthes GmbH
SD388.020
In Commercial Distribution

  • H981SD3880200 ()
  • 10705034706238 ()
SD388020

  • Bone awl, reusable

Cook - 00827002062627

Dilator with Handle
COOK INCORPORATED
G06262
In Commercial Distribution

  • 00827002062627 ()
JCD12.0-38-7.6-H-TCCS

  • Fascial tissue dilator, single-use

Cook - 00827002062610

Dilator with Handle
COOK INCORPORATED
G06261
In Commercial Distribution

  • 00827002062610 ()
JCD10.0-38-7.1-H-TCCS

  • Fascial tissue dilator, single-use

Captura Pro - 00827002570030

Forceps With Spike
COOK INCORPORATED
G57003
In Commercial Distribution

  • 10827002570037 ()
  • 00827002570030 ()
BF-3.3SM-230SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002570023

Forceps With Spike
COOK INCORPORATED
G57002
In Commercial Distribution

  • 10827002570020 ()
  • 00827002570023 ()
BF-3.3SM-230SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002569997

Forceps With Spike
COOK INCORPORATED
G56999
In Commercial Distribution

  • 10827002569994 ()
  • 00827002569997 ()
BF-2.8SJ-230SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002569980

Forceps With Spike
COOK INCORPORATED
G56998
In Commercial Distribution

  • 10827002569987 ()
  • 00827002569980 ()
BF-2.8SJ-230SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002569959

Forceps With Spike
COOK INCORPORATED
G56995
In Commercial Distribution

  • 10827002569956 ()
  • 00827002569959 ()
BF-2.8SJ-160SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002569942

Forceps With Spike
COOK INCORPORATED
G56994
In Commercial Distribution

  • 10827002569949 ()
  • 00827002569942 ()
BF-2.8SJ-160SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476967

Forceps With Spike
COOK INCORPORATED
G47696
In Commercial Distribution

  • 10827002476964 ()
  • 00827002476967 ()
BF-2.4SL-160SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476929

Forceps With Spike
COOK INCORPORATED
G47692
In Commercial Distribution

  • 10827002476926 ()
  • 00827002476929 ()
BF-2.2S-230SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476899

Forceps With Spike
COOK INCORPORATED
G47689
In Commercial Distribution

  • 10827002476896 ()
  • 00827002476899 ()
BF-2.2S-160SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476868

Forceps With Spike
COOK INCORPORATED
G47686
In Commercial Distribution

  • 10827002476865 ()
  • 00827002476868 ()
BF-2.2S-160SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002506961

Forceps With Spike
COOK INCORPORATED
G50696
In Commercial Distribution

  • 10827002506968 ()
  • 00827002506961 ()
BF-2.4SL-230SP-20

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002506978

Forceps With Spike
COOK INCORPORATED
G50697
In Commercial Distribution

  • 10827002506975 ()
  • 00827002506978 ()
BF-2.4SL-230SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476974

Forceps With Spike
COOK INCORPORATED
G47697
In Commercial Distribution

  • 10827002476971 ()
  • 00827002476974 ()
BF-2.4SL-160SP-40

  • Flexible endoscopic biopsy forceps, single-use

Captura Pro - 00827002476936

Forceps With Spike
COOK INCORPORATED
G47693
In Commercial Distribution

  • 10827002476933 ()
  • 00827002476936 ()
BF-2.2S-230SP-40

  • Flexible endoscopic biopsy forceps, single-use

VARIAX - 07613327398885

K-Wire with Stop
Stryker GmbH
705150
In Commercial Distribution

  • 07613327398885 ()

  • Length: 150.0 Millimeter
  • Diameter: 1.6 Millimeter
705150

  • Orthopaedic intraoperative positioning pin, single-use

M Earhook - 07630016880773

Standard with grip
Advanced Bionics AG
CI-5711-210
Not in Commercial Distribution

  • 07630016880773 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook

M Earhook - 07630016880766

Small with grip
Advanced Bionics AG
CI-5711-200
Not in Commercial Distribution

  • 07630016880766 ()


  • Cochlear implant/auditory brainstem implant sound processor earhook

Earhook - 07630016851193

Standard with grip
Advanced Bionics AG
CI-5710-210
Not in Commercial Distribution

  • 07630016851193 ()


  • Cochlear implant/auditory brainstem implant sound processor

Earhook - 07630016851186

Small with grip
Advanced Bionics AG
CI-5710-110
Not in Commercial Distribution

  • 07630016851186 ()


  • Cochlear implant/auditory brainstem implant sound processor

Kobold® Prostate HDR Template - 16 ga/5 Fr - 00815568021264

Labelled with CE
KOBOLD, LLC
802-000
In Commercial Distribution

  • 00815568021264 ()


  • Needle guide, single-use

Kobold® Prostate HDR Template - 17 ga/4 Fr - 00815568021257

Labelled with CE
KOBOLD, LLC
803-000
In Commercial Distribution

  • 00815568021257 ()


  • Needle guide, single-use

Kobold® Prostate HDR Template - 18 ga - 00815568021240

Labelled with CE
KOBOLD, LLC
804-000
In Commercial Distribution

  • 00815568021240 ()


  • Needle guide, single-use

Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr - 00815568021233

Labelled with CE
KOBOLD, LLC
811-000
In Commercial Distribution

  • 00815568021233 ()


  • Needle guide, single-use

Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr - 00815568021226

Labelled with CE
KOBOLD, LLC
812-000
In Commercial Distribution

  • 00815568021226 ()


  • Needle guide, single-use
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