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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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VITA VM 9 - J017BV13OCKA3PV30

VITAVM®13 ONE COLOR KIT A3 PASTE
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCKA3PV3
In Commercial Distribution

  • J017BV13OCKA3PV30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCKA2V30

VITAVM®13 ONE COLOR KIT A2 POWDER
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCKA2V3
In Commercial Distribution

  • J017BV13OCKA2V30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 13 - J017BV13OCKA2V20

VITA VM 13 ONE COLOR KIT A2 POWDER
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCKA2V2
In Commercial Distribution

  • J017BV13OCKA2V20 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCKA2PV30

VITAVM®13 ONE COLOR KIT A2 PASTE
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCKA2PV3
In Commercial Distribution

  • J017BV13OCKA2PV30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 13 - J017BV13OCKA2PV20

VITA VM 13 ONE COLOR KIT A2 PASTE
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCKA2PV2
In Commercial Distribution

  • J017BV13OCKA2PV20 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCK3M2V30

VITAVM®13 ONE COLOR KIT 3M2 POWDER
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCK3M2V3
In Commercial Distribution

  • J017BV13OCK3M2V30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCK3M2PV30

VITAVM®13 ONE COLOR KIT 3M2 PASTE
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCK3M2PV3
In Commercial Distribution

  • J017BV13OCK3M2PV30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCK2M2V30

VITAVM®13 ONE COLOR KIT 2M2 POWDER
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCK2M2V3
In Commercial Distribution

  • J017BV13OCK2M2V30 ()


  • Dental appliance fabrication material, ceramic

VITA VM 13 - J017BV13OCK2M2V20

VITA VM 13 ONE COLOR KIT 2M2 POWDER
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCK2M2V2
In Commercial Distribution

  • J017BV13OCK2M2V20 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV13OCK2M2PV30

VITAVM®13 ONE COLOR KIT 2M2 PASTE
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV13OCK2M2PV3
In Commercial Distribution

  • J017BV13OCK2M2PV30 ()


  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228764611

IQ,LP ONE,Enamel Effect Shade 6,L-6,4g
Gc America Inc.
876461
In Commercial Distribution

  • J0228764611 ()
876461

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228764501

Initial IQ,LP ONE/NF,Refresh Liquid,8ml
Gc America Inc.
876450
In Commercial Distribution

  • J0228764501 ()
876450

  • Dental appliance fabrication material, ceramic

Mini Stealth All-Suture Anchor - 00811714036397

Mini Stealth All-Suture Anchor, with one #2 Suture
RESPONSIVE ORTHOPEDICS LLC
285951
In Commercial Distribution

  • 00811714036397 ()
285951

  • Tendon/ligament bone anchor, non-bioabsorbable

Mini Stealth All-Suture Anchor - 00811714035796

Mini Stealth All-Suture Anchor, with one #2 Suture
RESPONSIVE ORTHOPEDICS LLC
911000-0001
In Commercial Distribution

  • 00811714035796 ()
911000-0001

  • Tendon/ligament bone anchor, non-bioabsorbable

Mustang Suture Anchor - 00811714035598

Mustang Suture Anchor, 4.5mm with one suture tape
RESPONSIVE ORTHOPEDICS LLC
916000-4500
In Commercial Distribution

  • 00811714035598 ()
916000-4500

  • Tendon/ligament bone anchor, non-bioabsorbable

KYPHON One-Step Osteo Introducer System, Trocar and Diamond - 00763000025564

INTRODUCER T15J OIS ONE STEP TRO AND DIA
MEDTRONIC SOFAMOR DANEK, INC.
T15J
In Commercial Distribution

  • 00763000025564 ()


  • Bone access channel kit

One third tubular locking plate, 25mm/2 holes - EMAH10007000020

One third tubular locking plate, 25mm/2 holes
mahe medical gmbh
100-0700-002
In Commercial Distribution

  • EMAH10007000020 ()

  • Length: 25.0 Millimeter
100-0700-002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 121mm/10 holes - EMAH10007000100

One third tubular locking plate, 121mm/10 holes
mahe medical gmbh
100-0700-010
In Commercial Distribution

  • EMAH10007000100 ()

  • Length: 121.0 Millimeter
100-0700-010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 109mm/9 holes - EMAH10007000090

One third tubular locking plate, 109mm/9 holes
mahe medical gmbh
100-0700-009
In Commercial Distribution

  • EMAH10007000090 ()

  • Length: 109.0 Millimeter
100-0700-009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 97mm/8 holes - EMAH10007000080

One third tubular locking plate, 97mm/8 holes
mahe medical gmbh
100-0700-008
In Commercial Distribution

  • EMAH10007000080 ()

  • Length: 97.0 Millimeter
100-0700-008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 85mm/7 holes - EMAH10007000070

One third tubular locking plate, 85mm/7 holes
mahe medical gmbh
100-0700-007
In Commercial Distribution

  • EMAH10007000070 ()

  • Length: 85.0 Millimeter
100-0700-007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 73mm/6 holes - EMAH10007000060

One third tubular locking plate, 73mm/6 holes
mahe medical gmbh
100-0700-006
In Commercial Distribution

  • EMAH10007000060 ()

  • Length: 73.0 Millimeter
100-0700-006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 61mm/5 holes - EMAH10007000050

One third tubular locking plate, 61mm/5 holes
mahe medical gmbh
100-0700-005
In Commercial Distribution

  • EMAH10007000050 ()

  • Length: 61.0 Millimeter
100-0700-005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 49mm/4 holes - EMAH10007000040

One third tubular locking plate, 49mm/4 holes
mahe medical gmbh
100-0700-004
In Commercial Distribution

  • EMAH10007000040 ()

  • Length: 49.0 Millimeter
100-0700-004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 37mm/3 holes - EMAH10007000030

One third tubular locking plate, 37mm/3 holes
mahe medical gmbh
100-0700-003
In Commercial Distribution

  • EMAH10007000030 ()

  • Length: 37.0 Millimeter
100-0700-003

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Polar - 00885556758038

60/25 ONE PIECE DO BROACH HANDLE RT
Smith & Nephew, Inc.
E0016600-4
In Commercial Distribution

  • 00885556758038 ()
E0016600-4

  • Orthopaedic broach

Polar - 00885556758021

60/25 ONE PIECE DO BROACH HANDLE LT
Smith & Nephew, Inc.
E0016600-3
In Commercial Distribution

  • 00885556758021 ()
E0016600-3

  • Orthopaedic broach

Polar - 00885556758014

80/45 ONE PIECE DO BROACH HANDLE RT
Smith & Nephew, Inc.
E0016600-2
In Commercial Distribution

  • 00885556758014 ()
E0016600-2

  • Orthopaedic broach

Polar - 00885556758007

80/45 ONE PIECE DO BROACH HANDLE LT
Smith & Nephew, Inc.
E0016600-1
In Commercial Distribution

  • 00885556758007 ()
E0016600-1

  • Orthopaedic broach

One third tubular locking plate, 145mm/12 holes - EMAH10007000120

One third tubular locking plate, 145mm/12 holes
mahe medical gmbh
100-0700-012
In Commercial Distribution

  • EMAH10007000120 ()

  • Length: 145.0 Millimeter
100-0700-012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

One third tubular locking plate, 133mm/11 holes - EMAH10007000110

One third tubular locking plate, 133mm/11 holes
mahe medical gmbh
100-0700-011
In Commercial Distribution

  • EMAH10007000110 ()

  • Length: 133.0 Millimeter
100-0700-011

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Invenio - 16931918115382

Surgical Gown_Set-In sleeve_Soft_Large_Extra Long_W/ one hand towel_Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-7022-S1
In Commercial Distribution

  • 26931918115389 ()
  • 16931918115382 ()


  • Surgical gown, single-use

Invenio - 16931918127064

Surgical Gown_Set-In sleeve_Soft_XL_Extra Long_W/ one hand towel_Sterile_26ea/cs
GRI Medical & Electronic Technology Co., Ltd.
i90-7032-S1
In Commercial Distribution

  • 26931918127061 ()
  • 16931918127064 ()


  • Surgical gown, single-use

Alleset00000 - 16931918126913

Surgical Gown_Set-In sleeve_Standard_Large_Extra Long_W/ one hand towel_Sterile_28ea/cs
GRI Medical & Electronic Technology Co., Ltd.
SF90-8022-S1
In Commercial Distribution

  • 26931918126910 ()
  • 16931918126913 ()


  • Surgical gown, single-use

Alleset - 16931918125916

Alleset Gown_no reinforcement_X-Large_35g SMS_With one towel_without CSR_Handi-Bin_468ea/cs
GRI Medical & Electronic Technology Co., Ltd.
90-2030-T1-HB
In Commercial Distribution

  • 06931918125919 ()
  • 16931918125916 ()


  • Surgical gown, single-use

GC Initial™ - 15400556700416

Initial IQ,LP ONE/NF,Refresh Liquid,8ml
Gc America Inc.
876450
In Commercial Distribution

  • 15400556700416 ()
876450

  • Dental appliance fabrication material, ceramic

GC Initial™ - 15400556700409

Initial IQ,LP ONE/NF,Diluting Liquid,8ml
Gc America Inc.
876449
In Commercial Distribution

  • 15400556700409 ()
876449

  • Dental appliance fabrication material, ceramic

GC Initial™ - 15400556700324

IQ,LP ONE,Enamel Effect Shade 6,L-6,4g
Gc America Inc.
876461
In Commercial Distribution

  • 15400556700324 ()
876461

  • Dental appliance fabrication material, ceramic

DeRoyal - 00749756556637

Liner/Lid Assembly with one Elbow 3200 ml
DEROYAL INDUSTRIES, INC.
71-9301
In Commercial Distribution

  • 50749756556632 ()
  • 00749756556637 ()


  • Surgical suction system collection container, single-use

DeRoyal - 00749756556576

Liner/Lid Assembly with one Elbow 1800 ml
DEROYAL INDUSTRIES, INC.
71-9201
In Commercial Distribution

  • 50749756556571 ()
  • 00749756556576 ()


  • Surgical suction system collection container, single-use

DeRoyal - 00749756556491

Liner/Lid Assembly with one Elbow 1300 ml
DEROYAL INDUSTRIES, INC.
71-9101
In Commercial Distribution

  • 50749756556496 ()
  • 00749756556491 ()


  • Surgical suction system collection container, single-use

STOPCOCKS - 00886333201426

STOPCOCKS. One Way Stopcock W/Male Luer Lock
ARGON MEDICAL DEVICES, INC.
041216800A
In Commercial Distribution

  • 20886333201420 ()
  • 00886333201426 ()
041216800A

  • Fluid transfer set, general-purpose

3 DEGREE - 18257200059393

36MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6360
In Commercial Distribution

  • 18257200059393 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059386

34MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6340
In Commercial Distribution

  • 18257200059386 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059379

32MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6320
In Commercial Distribution

  • 18257200059379 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059362

30MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6300
In Commercial Distribution

  • 18257200059362 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059355

28MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6280
In Commercial Distribution

  • 18257200059355 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059348

26MM ONE LEVEL CERVICAL PLATE ASSEMBLY 3DEG ACPS
Orthofix US LLC
60-6260
In Commercial Distribution

  • 18257200059348 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059331

24MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6240
In Commercial Distribution

  • 18257200059331 ()


  • Spinal fixation plate, non-bioabsorbable

3 DEGREE - 18257200059324

22MM ONE LEVEL CERVICAL PLATE ASSEMBLY, 3DEG ACPS
Orthofix US LLC
60-6220
In Commercial Distribution

  • 18257200059324 ()


  • Spinal fixation plate, non-bioabsorbable
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