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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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U2™ Hip - 04719872168461

Acetabular cup liner trial, ID 28mm, 10°×50mm
UNITED ORTHOPEDIC CORP.
1403-6450
In Commercial Distribution

  • 04719872168461 ()

  • ID 28mm, 10°×50mm
1403-6450

  • Acetabulum prosthesis trial, prefabricated, reusable

U2™ Hip - 04719872168454

Acetabular cup liner trial, ID 28mm, 10°×48mm
UNITED ORTHOPEDIC CORP.
1403-6448
In Commercial Distribution

  • 04719872168454 ()

  • ID 28mm, 10°×48mm
1403-6448

  • Acetabulum prosthesis trial, prefabricated, reusable

Ontrak - 10841522129254

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129254 ()

  • 32 cm-42 cm ID
016-0077-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129247

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129247 ()

  • 12-20 cm/5-8in ID
015-0118-05Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129230

CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129230 ()

  • 24-32 cm/ 9-13 " ID
015-0068-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129223

CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129223 ()

  • 28 cm/ 7-10" ID
015-0067-05Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522123870

ABP CUFF,SPACELABS,1T,XLADULT,SPU,20/BX
Statcorp Medical
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522123870 ()

  • 42 cm-50 cm ID
015-4250-00

  • Blood pressure cuff, single-use

NeuraGen® - 10381780026518

NeuraGen® Nerve Guide 5mm (ID) X 3cm (Length)
Integra Lifesciences Corporation
PNG530
In Commercial Distribution

  • 10381780026518 ()
  • M269PNG5301 ()

  • 5mm (ID) x3cm (Length)
PNG-530

  • Nerve guide, animal-derived

CUSA® Excel - 10381780025924

CUSA® Excel 23kHz 1.98mm Curved Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4603S
In Commercial Distribution

  • 30381780025928 ()
  • 10381780025924 ()
  • M269C4603S15 ()

  • 1.98mm ID; 23kHz frequency
C4603S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® Excel - 10381780025917

CUSA® Excel 23kHz 1.98mm Straight Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4602S
In Commercial Distribution

  • 30381780025911 ()
  • 10381780025917 ()
  • M269C4602S14 ()

  • 1.98mm ID; 23kHz frequency
C4602S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

NeuraGen® - 10381780071860

NeuraGen® Nerve Guide 7mm (ID) X 2cm (Length)
Integra Lifesciences Corporation
PNG720
In Commercial Distribution

  • 10381780071860 ()
  • M269PNG7201 ()

  • 7mm (ID) x2cm (Length)
PNG-720

  • Nerve guide, animal-derived

NeuraGen® - 10381780071853

NeuraGen® Nerve Guide 6mm (ID) X 2cm (Length)
Integra Lifesciences Corporation
PNG620
In Commercial Distribution

  • 10381780071853 ()
  • M269PNG6201 ()

  • 6mm (ID) x2cm (Length)
PNG-620

  • Nerve guide, animal-derived

NeuraGen® - 10381780071822

NeuraGen® Nerve Guide 1.5mm (ID) X 3cm (Length)
Integra Lifesciences Corporation
PNG130
In Commercial Distribution

  • 10381780071822 ()
  • M269PNG1301 ()

  • 1.5mm (ID) x3cm (Length)
PNG-130

  • Nerve guide, animal-derived

N.A. - J011602839550

Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-839-55
In Commercial Distribution

  • J011602839550 ()
  • J011602839551 ()


  • Orthodontic palate expander screw, bonded

N.A. - J011602838550

Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-838-55
In Commercial Distribution

  • J011602838550 ()
  • J011602838551 ()


  • Orthodontic palate expander screw, bonded

FB - 03573026099923

FB is a reagent associated to API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300), rapid ID 32 STREP (32 600)
BIOMERIEUX SA
70562
In Commercial Distribution

  • 03573026099923 ()


  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit

EPI-DERM - 00852260000128

Natural Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
Biodermis LLC
FLP-1
In Commercial Distribution

  • 00852260000128 ()
FLP-1

  • Scar-management dressing, reusable

EPI-DERM - 00852260000111

Natural Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair
Biodermis LLC
FLP-51
In Commercial Distribution

  • 00852260000111 ()
FLP-51

  • Scar-management dressing, reusable

N/AN/A - 00884908104301

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STAINLESS STEEL WIREW/60C & 22GA NEEDLE
Medical Components, Inc.
MR1903622
Not in Commercial Distribution

  • 30884908104302 ()
  • 00884908104301 ()
  • 50884908104306 ()
MR1903622

  • Vascular catheter introduction needle

N/AN/A - 00884908104202

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STAINLESS STEEL WIREW/60C & 22GA NEEDLE
Medical Components, Inc.
MR1902622
Not in Commercial Distribution

  • 30884908104203 ()
  • 00884908104202 ()
  • 50884908104207 ()
MR1902622

  • Vascular catheter introduction needle
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