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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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Blue Sky Bio, LLC - 00810060223703

Bio | Cut Guide Tube 5.24 OD x 5.04 ID x 4mm LNF
BLUE SKY BIO LLC
TUBE524-504-4LNF
In Commercial Distribution

  • 00810060223703 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060223697

Bio | Cut Guide Tube 5.24 OD x 5.04 ID x 4mm L
BLUE SKY BIO LLC
TUBE524-504-4L
In Commercial Distribution

  • 00810060223697 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060223680

BIO | Cut Guide Tube 5.0 OD x 2.3 ID x 5mm L
BLUE SKY BIO LLC
TUBE5-23-5L
In Commercial Distribution

  • 00810060223680 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060223673

BIO | Cut Guide tube 5.0 OD x 2.1 ID x 5mm L
BLUE SKY BIO LLC
TUBE5-21-5L
In Commercial Distribution

  • 00810060223673 ()


  • Surgical torque wrench adaptor

Blue Sky Bio, LLC - 00810060223659

Bio | Cut Guide Tube 5.1 OD x 4.1 ID x 3.5mm L
BLUE SKY BIO LLC
TUBE51-41-35L
In Commercial Distribution

  • 00810060223659 ()


  • Surgical torque wrench adaptor

N/A - 00884908143652

21GA (0.85MM OD;0.60MM ID) X 7CM SAFETY NEEDLE W/ECHO TIP
Medical Components, Inc.
DMC217S
In Commercial Distribution

  • 50884908143657 ()
  • 00884908143652 ()


  • Vascular catheter introduction needle

N/A - 00884908143621

21GA (0.85MM OD;0.60MM ID) X 5CM SAFETY NEEDLE W/ECHO TIP
Medical Components, Inc.
DMC215S
In Commercial Distribution

  • 50884908143626 ()
  • 00884908143621 ()


  • Vascular catheter introduction needle

R3 - 00885556192030

R3 20 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 66/70MM
Smith & Nephew, Inc.
71934558
In Commercial Distribution

  • 00885556192030 ()
71934558

  • Ceramic acetabular liner

HistoCore PELORIS - 09349458005566

The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection tag, or the lot or batch number of a reagent.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
HistoCore PELORIS 3 Barcode Scanner Kit
In Commercial Distribution

  • 09349458005566 ()
S45.4508

  • Tissue processor IVD, automated/semi-automated

ID NOW COVID-19 2.0 Control Swab Kit - 00811877011361

Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use.
Alere Scarborough, Inc.
192-080
In Commercial Distribution

  • 00811877011361 ()


  • SARS-CoV-2 nucleic acid IVD, control
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