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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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ImmunoCAP Allergen g12, Cultivated rye
Phadia AB
14-4101-01
In Commercial Distribution

  • 07333066001081 ()
14-4101-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g6, Timothy
Phadia AB
14-4100-01
In Commercial Distribution

  • 07333066001074 ()
14-4100-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Dilution Plate, Phadia 250
Phadia AB
12-3907-08
In Commercial Distribution

  • 07333066001036 ()
12-3907-08

  • Plasma protein IVD, reagent
Lyra Adenovirus Assay
QUIDEL CORPORATION
Adenovirus Assay
In Commercial Distribution

  • 30014613311133 ()
M113

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), bed-mounted Robotic Control Unit (RCU) Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Units are affixed firmly to the surgical bed via the Robotic Control Unit Support System, which includes the RCUSS Fixator (UDI # 07290018151112) and an Extension Rail (UDI # 07290018151129). The RCUSS Fixator is attached to the Robotic Control Units. The RCUSS Fixator can be attached to the surgical table directly or through the Extension Rail.
MOMENTIS SURGICAL LTD
-
In Commercial Distribution

  • 27290018151109 ()
FP-04-0005

  • Surgical instrument assist arm system, manually-adjusted
No Description
Maquet Critical Care AB
6686860
In Commercial Distribution

  • 07325710012420 ()


  • Anaesthesia workstation, general-purpose
No Description
BIOGENEX LABORATORIES
AM338-5M
In Commercial Distribution

  • 00810119672049 ()

  • Total Volume: 6 Milliliter
AM338-5M

  • CD45 leukocyte common antigen cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM358-5M
In Commercial Distribution

  • 00810119671868 ()

  • Total Volume: 6 Milliliter
AM358-5M

  • Mucin IVD, antibody
No Description
BIO CONCEPT Co., Ltd.
333220
In Commercial Distribution

  • 06947600312383 ()


  • Dental implant system
No Description
BIO CONCEPT Co., Ltd.
333200
In Commercial Distribution

  • 06947600312369 ()


  • Dental implant system
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