SEARCH RESULTS FOR: 【溦信88931766】i换脸张子枫11V4G最全所有视频资源全部作品合集.ldb(8048 results)

Export results
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

Show Filters

The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile
Jiang Xi Sanxin Medtec Co., Ltd.
Type A (ear-loop type),size I,Sterile 9.5×14.5 Level 2
In Commercial Distribution

  • 16945060520130 ()
  • 06945060520133 ()
  • 26945060520137 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control). One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9549-0
In Commercial Distribution

  • 00607158000076 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9552-0
In Commercial Distribution

  • 00607158000045 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control). One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9546-0
In Commercial Distribution

  • 00607158000038 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220515 ()


  • Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220508 ()


  • Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220492 ()


  • Indirect flat panel x-ray detector
The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males whohave Norwood- Hamilton Classifications of lla - V patterns of hair loss and to treat Androgenetic Alopecia and promotehair growth in females who have Ludwig-Savin Scale I-1 to -4. 1l-1. l-2 or ffontal patterns of hair loss: both with Fitzpatrick Skin Types I - IV.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
SZ-22A
In Commercial Distribution

  • 00850062024557 ()


  • Hair growth laser device
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
200X25X8 MM, 40 CC
In Commercial Distribution

  • 00816986020518 ()
SGFS-040

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
100X25X8 MM, 20 CC
In Commercial Distribution

  • 00816986020501 ()
SGFS-020

  • Synthetic bone graft
< 1 ... 779 780 781 782 783 ... 805 >