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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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A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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
SERUM DRUG SCREEN LEVEL 5
UTAK LABORATORIES, INC.
DS 5 S ID
In Commercial Distribution

  • B800DS5SID5 ()
  • B800DS5SID0 ()

  • Total Volume: 3 Milliliter
DS 5 S ID

  • Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 4
UTAK LABORATORIES, INC.
DS 4 S ID
In Commercial Distribution

  • B800DS4SID5 ()
  • B800DS4SID0 ()

  • Total Volume: 3 Milliliter
DS 4 S ID

  • Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 3
UTAK LABORATORIES, INC.
DS 3 S ID
In Commercial Distribution

  • B800DS3SID5 ()
  • B800DS3SID0 ()

  • Total Volume: 3 Milliliter
DS 3 S ID

  • Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 2
UTAK LABORATORIES, INC.
DS 2 S ID
In Commercial Distribution

  • B800DS2SID0 ()
  • B800DS2SID5 ()

  • Total Volume: 3 Milliliter
DS 2 S ID

  • Benzodiazepine group IVD, control
SERUM DRUG SCREEN LEVEL 1
UTAK LABORATORIES, INC.
DS 1 S ID
In Commercial Distribution

  • B800DS1SID0 ()
  • B800DS1SID5 ()

  • Total Volume: 3 Milliliter
DS 1 S ID

  • Benzodiazepine group IVD, control
Working Tube Shaft, straight 90°, iLESSYS DELTA
Joimax GmbH
WTS901304
In Commercial Distribution

  • 04250337110422 ()

  • L 91mm /ID 10.2mm /OD 13.7mm, radiolucent
WTS901304

  • Endoscope sheath, reusable
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