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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ANESTHESIA CIRCUIT PEDS-LF
MEDLINE INDUSTRIES, INC.
DYNJAP10001
In Commercial Distribution

  • 10193489682953 ()
  • 40193489682954 ()
DYNJAP10001

  • General surgical procedure kit, non-medicated, single-use
ANESTHESIA CIRCUIT ADULT-LF
MEDLINE INDUSTRIES, INC.
DYNJAA0341
In Commercial Distribution

  • 10193489682946 ()
  • 40193489682947 ()
DYNJAA0341

  • General surgical procedure kit, non-medicated, single-use
LAPAROSCOPY/GENERAL PACK
MEDLINE INDUSTRIES, INC.
DYNJ52946D
In Commercial Distribution

  • 10193489682922 ()
  • 40193489682923 ()
DYNJ52946D

  • General surgical procedure kit, non-medicated, single-use
CATARACT PACK
MEDLINE INDUSTRIES, INC.
DYNJ34123I
In Commercial Distribution

  • 10193489682847 ()
DYNJ34123I

  • General surgical procedure kit, non-medicated, single-use
HAND PACK
MEDLINE INDUSTRIES, INC.
DYNJ52570B
In Commercial Distribution

  • 10193489682830 ()
  • 40193489682831 ()
DYNJ52570B

  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ52571B
In Commercial Distribution

  • 10193489682823 ()
  • 40193489682824 ()
DYNJ52571B

  • General surgical procedure kit, non-medicated, single-use
KNEE PACK
MEDLINE INDUSTRIES, INC.
DYNJ51643B
In Commercial Distribution

  • 10193489682816 ()
  • 40193489682817 ()
DYNJ51643B

  • General surgical procedure kit, non-medicated, single-use
Acromion Osteotomy Guide and Model
Materialise NV
O-01-0-820000-0011-010
In Commercial Distribution

  • 05420060343360 ()
O-01-0-820000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Pediatric Radius/Ulna Model
Materialise NV
UEA-MA10-00-01
In Commercial Distribution

UEA-MA10-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
LEFT HEART CATH PK
MEDLINE INDUSTRIES, INC.
DYNJ37684J
In Commercial Distribution

  • 10193489682786 ()
  • 40193489682787 ()
DYNJ37684J

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART CDS
MEDLINE INDUSTRIES, INC.
CDS980952S
In Commercial Distribution

  • 10193489682779 ()
CDS980952S

  • General surgical procedure kit, medicated
GENERAL LAPAROTOMY PACK POB-LF
MEDLINE INDUSTRIES, INC.
DYNJ33518D
In Commercial Distribution

  • 10193489682755 ()
  • 40193489682756 ()
DYNJ33518D

  • General surgical procedure kit, non-medicated, single-use
OB PACK
MEDLINE INDUSTRIES, INC.
DYNJ57633B
In Commercial Distribution

  • 10193489682748 ()
  • 40193489682749 ()
DYNJ57633B

  • General surgical procedure kit, non-medicated, single-use
Humerus Osteotomy Guide and Model
Materialise NV
O-01-0-105000-0011-010
In Commercial Distribution

O-01-0-105000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Pediatric Radius/Ulna Osteotomy Guide and Model
Materialise NV
UEA-MA01-00-01
In Commercial Distribution

UEA-MA01-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
Radius/Ulna Osteotomy Guide and Model
Materialise NV
O-01-0-101000-0011-010
In Commercial Distribution

O-01-0-101000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Bone Model Lower Extremity
Materialise NV
O-01-0-300000-0121-020
In Commercial Distribution

  • 05420060343254 ()
O-01-0-300000-0121-020

  • Custom-made organ/bone anatomy model/surgical guide kit
Bone Model Upper Extremity
Materialise NV
O-01-0-100000-0121-020
In Commercial Distribution

  • 05420060343247 ()
O-01-0-100000-0121-020

  • Custom-made organ/bone anatomy model/surgical guide kit
Acromion Osteotomy Model
Materialise NV
O-01-0-820000-0111-010
In Commercial Distribution

  • 05420060343230 ()
O-01-0-820000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Acromion Osteotomy Guide
Materialise NV
O-01-0-820000-0211-010
In Commercial Distribution

  • 05420060343223 ()
O-01-0-820000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Guide Lower Extremity
Materialise NV
O-01-0-300000-0221-010
In Commercial Distribution

  • 05420060343209 ()
O-01-0-300000-0221-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Guide Upper Extremity
Materialise NV
O-01-0-100000-0221-010
In Commercial Distribution

  • 05420060343186 ()
O-01-0-100000-0221-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Bone Model
Materialise NV
O-00-3-000000-0001-000
In Commercial Distribution

O-00-3-000000-0001-000

  • Custom-made organ/bone anatomy model/surgical guide kit
Femur Osteotomy Model
Materialise NV
O-01-0-306000-0111-010
In Commercial Distribution

  • 05420060343117 ()
O-01-0-306000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Femur Osteotomy Guide
Materialise NV
O-01-0-306000-0211-010
In Commercial Distribution

  • 05420060343100 ()
O-01-0-306000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Tibia/Fibula Osteotomy Model
Materialise NV
O-01-0-303000-0111-010
In Commercial Distribution

  • 05420060343094 ()
O-01-0-303000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Tibia/Fibula Osteotomy Guide
Materialise NV
O-01-0-303000-0211-010
In Commercial Distribution

  • 05420060343087 ()
O-01-0-303000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Clavicle Osteotomy Model
Materialise NV
O-01-0-828000-0111-000
In Commercial Distribution

  • 05420060343070 ()
O-01-0-828000-0111-000

  • Custom-made organ/bone anatomy model/surgical guide kit
Clavicle Osteotomy Guide
Materialise NV
O-01-0-828000-0211-000
In Commercial Distribution

  • 05420060343063 ()
O-01-0-828000-0211-000

  • Custom-made organ/bone anatomy model/surgical guide kit
Hand Osteotomy Model
Materialise NV
O-01-0-200000-0111-010
In Commercial Distribution

  • 05420060343056 ()
O-01-0-200000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Hand Osteotomy Guide
Materialise NV
O-01-0-200000-0211-010
In Commercial Distribution

  • 05420060343049 ()
O-01-0-200000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Humerus Osteotomy Model
Materialise NV
O-01-0-105000-0111-010
In Commercial Distribution

  • 05420060343032 ()
O-01-0-105000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Humerus Osteotomy Guide
Materialise NV
O-01-0-105000-0211-010
In Commercial Distribution

  • 05420060343025 ()
O-01-0-105000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Radius/Ulna Osteotomy Model
Materialise NV
O-01-0-101000-0111-010
In Commercial Distribution

  • 05420060343018 ()
O-01-0-101000-0111-010

  • Custom-made organ/bone anatomy model/surgical guide kit
Radius/Ulna Osteotomy Guide
Materialise NV
O-01-0-101000-0211-010
In Commercial Distribution

  • 05420060343001 ()
O-01-0-101000-0211-010

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Biomet Spring Pin Guide kit
Materialise NV
KNC-ZB02-00-02
In Commercial Distribution

  • 05420060310461 ()
KNC-ZB02-00-02

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Biomet Spring Pin Guide and Bone Model kit
Materialise NV
KNC-ZB01-00-02
In Commercial Distribution

  • 05420060310430 ()
KNC-ZB01-00-02

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Zimmer Pin Guide kit
Materialise NV
KNC-ZB04-00-01
In Commercial Distribution

  • 05420060310140 ()
KNC-ZB04-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Zimmer Pin Guide and Bone Model kit
Materialise NV
KNC-ZB03-00-01
In Commercial Distribution

  • 05420060310133 ()
KNC-ZB03-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Biomet Pin Guide kit
Materialise NV
KNC-ZB02-00-01
In Commercial Distribution

  • 05420060310126 ()
KNC-ZB02-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB CT TKA Biomet Pin Guide and Bone Model kit
Materialise NV
KNC-ZB01-00-01
In Commercial Distribution

  • 05420060310119 ()
KNC-ZB01-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
MRI Zimmer Guide for Partial Knee Arthroplasty
Materialise NV
KNM-ZB14-00-01
In Commercial Distribution

  • 05420060310102 ()
KNM-ZB14-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
MRI Zimmer Guide and Bone Model for Partial Knee Arthroplasty
Materialise NV
KNM-ZB13-00-01
In Commercial Distribution

  • 05420060310096 ()
KNM-ZB13-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI PKA Guide kit
Materialise NV
KNM-ZB12-00-01
In Commercial Distribution

  • 05420060310089 ()
KNM-ZB12-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI PKA Guide and Bone Model kit
Materialise NV
KNM-ZB11-00-01
In Commercial Distribution

  • 05420060310072 ()
KNM-ZB11-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI TKA Cut-through Guide kit
Materialise NV
KNM-ZB06-00-01
In Commercial Distribution

  • 05420060310065 ()
KNM-ZB06-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI TKA Cut-through Guide and Bone Model kit
Materialise NV
KNM-ZB05-00-01
In Commercial Distribution

  • 05420060310058 ()
KNM-ZB05-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI TKA Zimmer Pin Guide kit
Materialise NV
KNM-ZB04-00-01
In Commercial Distribution

  • 05420060310041 ()
KNM-ZB04-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI TKA Zimmer Pin Guide and Bone Model kit
Materialise NV
KNM-ZB03-00-01
In Commercial Distribution

  • 05420060310034 ()
KNM-ZB03-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
ZB MRI TKA Biomet Pin Guide kit
Materialise NV
KNM-ZB02-00-01
In Commercial Distribution

  • 05420060310027 ()
KNM-ZB02-00-01

  • Custom-made organ/bone anatomy model/surgical guide kit
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