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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ARCHES MEMORIA shape B V bend 17x25
LEONE SPA
C6142V917
In Commercial Distribution

  • 08033707006633 ()
C6142V917

  • Orthodontic archwire
ARCHES MEMORIA shape B V bend 17x25
LEONE SPA
C6142V17
In Commercial Distribution

  • 08033707006619 ()
C6142V17

  • Orthodontic archwire
ARCHES MEMORIA shape B V bend 18
LEONE SPA
C6140V18
In Commercial Distribution

  • 08033707006480 ()
C6140V18

  • Orthodontic archwire
ARCHES MEMORIA shape B V bend 16
LEONE SPA
C6140V16
In Commercial Distribution

  • 08033707006473 ()
C6140V16

  • Orthodontic archwire
ARCHES MEMORIA shape A V bend 19x25
LEONE SPA
C6045V19
In Commercial Distribution

  • 08033707006350 ()
C6045V19

  • Orthodontic archwire
ARCHES MEMORIA shape A V bend 16
LEONE SPA
C6040V16
In Commercial Distribution

  • 08033707006169 ()
C6040V16

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 19x25
LEONE SPA
C6445V919
In Commercial Distribution

  • 08033707007586 ()
C6445V919

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 17x25
LEONE SPA
C6442V917
In Commercial Distribution

  • 08033707007548 ()
C6442V917

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 16x22
LEONE SPA
C6442V916
In Commercial Distribution

  • 08033707007531 ()
C6442V916

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 17x25
LEONE SPA
C6442V17
In Commercial Distribution

  • 08033707007524 ()
C6442V17

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 16x22
LEONE SPA
C6442V16
In Commercial Distribution

  • 08033707007517 ()
C6442V16

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 16x16
LEONE SPA
C6441V16
In Commercial Distribution

  • 08033707007456 ()
C6441V16

  • Orthodontic archwire
ARCHES MEMORIA shape E V bend 16
LEONE SPA
C6440V16
In Commercial Distribution

  • 08033707007388 ()
C6440V16

  • Orthodontic archwire
ARCHES MEMORIA shape D V bend 19x25
LEONE SPA
C6345V19
In Commercial Distribution

  • 08033707007296 ()
C6345V19

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 19x25
LEONE SPA
C6245V19
In Commercial Distribution

  • 08033707007005 ()
C6245V19

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 17x25
LEONE SPA
C6242V917
In Commercial Distribution

  • 08033707006978 ()
C6242V917

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 17x25
LEONE SPA
C6242V17
In Commercial Distribution

  • 08033707006954 ()
C6242V17

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 16x22
LEONE SPA
C6242V16
In Commercial Distribution

  • 08033707006947 ()
C6242V16

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 16x16
LEONE SPA
C6241V16
In Commercial Distribution

  • 08033707006886 ()
C6241V16

  • Orthodontic archwire
ARCHES MEMORIA shape C V bend 18
LEONE SPA
C6240V18
In Commercial Distribution

  • 08033707006824 ()
C6240V18

  • Orthodontic archwire
ARCHES MEMORIA shape A V bend 19x25
LEONE SPA
C6045V919
In Commercial Distribution

  • 08033707006367 ()
C6045V919

  • Orthodontic archwire
Repl. Cover,(White) LA-8Hr, Vela Shape II
SYNERON MEDICAL LTD
AS77802
Not in Commercial Distribution

  • 07290109950723 ()
  • 37290109950724 ()
  • 17290109950720 ()
AS77802

  • Multi-modality skin contouring system
S Shape Urethral Dilator Set Hydrophilic 8-20Fr
Well Lead Medical Co.,Ltd
U02A050210
In Commercial Distribution

  • 16944932769882 ()
  • 06944932769885 ()
  • 26944932769889 ()


  • Urethral dilator, single-use
SHEARS RIB HORSLEY STILLE S SHAPE ANG
TELEFLEX INCORPORATED
IPN017474
In Commercial Distribution

  • 54026704791113 ()
  • 14026704791115 ()
P14605

  • Bone cutting forceps, reusable
This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.
Gambro Renal Products, S.A. de C.V.
106283
In Commercial Distribution

  • 37332414055180 ()
  • 07332414055189 ()
106283

  • Haemodialysis blood tubing set, single-use
The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. Dynamic Mixers for automatic impression material mixing machines. • Correct ratio base and catalyst • Perfect 5:1 ratio from the very beginning • Delivering accurate ratio and static mixing nozzle combination • Minimizes waste
DXM CO., LTD
Red
In Commercial Distribution

  • 08800017901886 ()
  • 08800017901893 ()


  • Dental material mixing nozzle
The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. Dynamic Mixers for automatic impression material mixing machines. • Correct ratio base and catalyst • Perfect 5:1 ratio from the very beginning • Delivering accurate ratio and static mixing nozzle combination • Minimizes waste
DXM CO., LTD
Yellow
In Commercial Distribution

  • 08800017901862 ()
  • 08800017901879 ()
  • 08800017901855 ()


  • Dental material mixing nozzle
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389652673 ()
075-0075-11

  • Noninvasive device battery charger
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389625899 ()
075-0075-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389759020 ()
075-5891-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389759013 ()
075-5891-11

  • Noninvasive device battery charger
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389758993 ()
075-5890-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389758986 ()
075-5890-11

  • Noninvasive device battery charger
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389758962 ()
075-5889-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389758955 ()
075-5889-11

  • Noninvasive device battery charger
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389758931 ()
075-5888-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389758924 ()
075-5888-11

  • Noninvasive device battery charger
No Description
EMD Technologies
EPS SYS AG
In Commercial Distribution

  • 00055846500085 ()


  • Diagnostic x-ray system generator, stationary
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Pediatric (PED)
9321-8758 Québec Inc
Ankle Pediatric
In Commercial Distribution

  • 20628634832039 ()

  • PED S for Pediatric Small
  • PED M for Pediatric Medium
  • PED L for Pediatric Large
TBCP-01, TBCP-02,TBCP-03

  • Custom-made lower-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize an elbow with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03) for Adult (ADU)
9321-8758 Québec Inc
Elbow Adult
In Commercial Distribution

  • 30628634832180 ()

  • ADU S for adult small
  • ADU M for adult medium
  • ADU L for adult large
TBCoA-01, TBCoA-02, TBCoA-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between a layers of 3D stretchable knitted fabric and a layers of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Velcro closure separate. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult
In Commercial Distribution

  • 30628634832159 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
HBPA-01, HBPA-02,HBPA-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with velcro closure. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult with velcro closure
In Commercial Distribution

  • 30628634832104 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
TBPAV-01, TBPAV-02,TBPAV-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize a wrist, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace with zipper closure. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Wrist Adult with zipper closure
In Commercial Distribution

  • 30628634832098 ()

  • ADU S for Adult Small
  • ADU M for Adult Medium
  • ADU L for Adult Large
TBPAZ-01, TBPAZ-02,TBPAZ-03

  • Custom-made upper-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Ankle Adult Reinforced
In Commercial Distribution

  • 30628634832067 ()

  • ADU S for adult small
  • ADU M for adult medium
  • ADU L for adult large
TBCAR-01, TBCAR-02, TBCAR-03

  • Custom-made lower-limb orthosis
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03), Adult (ADU)
9321-8758 Québec Inc
Ankle Adult
In Commercial Distribution

  • 30628634832050 ()

  • ADU S for adult small
  • ADU M for adult medium
  • ADU L for adult large
TBCA-01, TBCA-02, TBCA-03

  • Custom-made lower-limb orthosis
Light Green Head Mask 2.4mm, Perf 12% for Elekta HeadSTEP™ System
Klarity Medical Products, LLC
RLG-ELH-2412C
In Commercial Distribution

  • 00817355023901 ()


  • Patient positioning thermoplastic mould material
Klarity Green IMRT Open Face Profile Frame Head Mask 3.2mm, AccuPerf (Reinforced) Extended Neckline
Klarity Medical Products, LLC
RG464-81W
In Commercial Distribution

  • 00817355023826 ()


  • Patient positioning thermoplastic mould material
Klarity Reloadable Head Mask 3.2mm, 9x10" Perf 42% for S-Type
Klarity Medical Products, LLC
R471SH
In Commercial Distribution

  • 00817355023802 ()


  • Patient positioning thermoplastic mould material
PelvicFix™ Bodycast with disposable frame solid 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-7A
In Commercial Distribution

  • 00817355023765 ()


  • Patient positioning thermoplastic mould material
PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-3A
In Commercial Distribution

  • 00817355023758 ()


  • Patient positioning thermoplastic mould material
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