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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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The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-31-5
In Commercial Distribution

  • 56971227400395 ()
  • 36971227400391 ()
  • 16971227400380 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-5
In Commercial Distribution

  • 36971227400384 ()
  • 16971227400380 ()
  • 56971227400388 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-8
In Commercial Distribution

  • 56971227400371 ()
  • 36971227400377 ()
  • 16971227400373 ()


  • Autoinjector needle
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
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
Collagen Nerve Protector
COLLAGEN MATRIX, INC.
ABS-12050W
In Commercial Distribution

  • 00813954027388 ()

  • 12.0 mm ID x 5.0 cm length
ABS-12050W

  • Nerve guide, animal-derived
Collagen Nerve Protector
COLLAGEN MATRIX, INC.
ABS-12025W
In Commercial Distribution

  • 00813954027371 ()

  • 12.0 mm ID x 2.5 cm length
ABS-12025W

  • Nerve guide, animal-derived
Collagen Nerve Protector
COLLAGEN MATRIX, INC.
ABS-6050W
In Commercial Distribution

  • 00813954027364 ()

  • 6.0 mm ID x 5.0 cm length
ABS-6050W

  • Nerve guide, animal-derived
Collagen Nerve Protector
COLLAGEN MATRIX, INC.
ABS-6025W
In Commercial Distribution

  • 00813954027357 ()

  • 6.0 mm ID x 2.5 cm length
ABS-6025W

  • Nerve guide, animal-derived
Collagen Nerve Protector
COLLAGEN MATRIX, INC.
ABS-4050W
In Commercial Distribution

  • 00813954027340 ()

  • 4.0 mm ID x 5.0 cm length
ABS-4050W

  • Nerve guide, animal-derived
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