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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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Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4522CT
Not in Commercial Distribution

  • M269PSS4522CT1 ()
  • 10381780117605 ()

  • 1.007 in L x .177 in dia
PSS4522CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4520LT
Not in Commercial Distribution

  • M269PSS4520LT1 ()
  • 10381780117599 ()

  • .927 in L x .177 in dia
PSS4520LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4520CT
Not in Commercial Distribution

  • M269PSS4520CT1 ()
  • 10381780117582 ()

  • .928 in L x .177 in dia
PSS4520CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4518LT
Not in Commercial Distribution

  • M269PSS4518LT1 ()
  • 10381780117575 ()

  • .849 in L x .177 in dia
PSS4518LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4518CT
Not in Commercial Distribution

  • M269PSS4518CT1 ()
  • 10381780117568 ()

  • .850 in L x .177 in dia
PSS4518CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4516LT
Not in Commercial Distribution

  • M269PSS4516LT1 ()
  • 10381780117551 ()

  • .770 in L x .177 in dia
PSS4516LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4516CT
Not in Commercial Distribution

  • M269PSS4516CT1 ()
  • 10381780117544 ()

  • .771 in L x .177 in dia
PSS4516CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4514LT
Not in Commercial Distribution

  • M269PSS4514LT1 ()
  • 10381780117537 ()

  • .691 in L x .177 in dia
PSS4514LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4514CT
Not in Commercial Distribution

  • M269PSS4514CT1 ()
  • 10381780117520 ()

  • .692 in L x .177 in dia
PSS4514CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The instrument tray base is part of the container which product number is 339950ND and that is used for transport and sterilization of instruments. It is also part of the container which product number is 339900ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
339920ND
Not in Commercial Distribution

  • M248339920ND1 ()
  • 10381780042723 ()


  • Device sterilization/disinfection container, reusable
The LapBox Power Contained Tissue Extraction System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be power morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-P01
In Commercial Distribution

  • 07290118830023 ()
  • 07290118830030 ()


  • Tissue extraction bag
The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-M01
In Commercial Distribution

  • 07290118830016 ()
  • 07290118830009 ()


  • Tissue extraction bag
222 Lower Molars, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF222IS
In Commercial Distribution

  • 10889950113100 ()


  • Tooth extraction forceps
151 Lower Universal, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF151IS
In Commercial Distribution

  • 10889950113094 ()


  • Tooth extraction forceps
150 Upper Universal, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF150IS
In Commercial Distribution

  • 10889950113087 ()


  • Tooth extraction forceps
1 Upper Anterior, Apical, IS Forceps
HU-FRIEDY MFG. CO., LLC
FAF1IS
In Commercial Distribution

  • 10889950113070 ()


  • Tooth extraction forceps
53L Upper Molar, Left, IS Forceps
HU-FRIEDY MFG. CO., LLC
F53LIS
In Commercial Distribution

  • 10889950113056 ()


  • Tooth extraction forceps
53R Upper Molar, Right, IS Forceps
HU-FRIEDY MFG. CO., LLC
F53RIS
In Commercial Distribution

  • 10889950113049 ()


  • Tooth extraction forceps
EV5C is an abdominal end-fire transducer.
Exact Imaging Inc
EV5C
In Commercial Distribution

  • 00628055481096 ()
EV-5C

  • Extracorporeal ultrasound imaging transducer, hand-held
EV9C is a transrectal end-fire transducer.
Exact Imaging Inc
EV9C
In Commercial Distribution

  • 00628055481041 ()
EV-9C

  • Rectal/vaginal ultrasound imaging transducer
Wakan-Matte Black - Sun is Life JY
Claudia Alan Inc
AYO0424BLK
In Commercial Distribution

  • 00628120774740 ()


  • Spectacle frame
Wakan-Matte Brown - Sun is Life JY
Claudia Alan Inc
AYO0424BRN
In Commercial Distribution

  • 00628120774733 ()


  • Spectacle frame
BBB-112 Grey is a heating pad
Sevenground Trading B.V.
BBB-112 Grey
In Commercial Distribution

  • 08719699636644 ()


  • Insect bite/sting hyperthermia device
K-NW-237 is a nasal wash bottle
Sevenground Trading B.V.
K-NW-237
In Commercial Distribution

  • 08719699632530 ()


  • Nasal irrigation applicator
K-MB-716 is an Adjustable maternity Belt
Sevenground Trading B.V.
K-MB-716
In Commercial Distribution

  • 08719699632394 ()


  • Abdominal binder, reusable
BBB-112 Blue is a heating pad
Sevenground Trading B.V.
BBB-112 Blue
In Commercial Distribution

  • 08719699636651 ()


  • Insect bite/sting hyperthermia device
The device is included 2 pouch
DFI CO.,LTD
6407
Not in Commercial Distribution

  • 08806141302896 ()


  • Total cholesterol lipid IVD, reagent
SUDOTEST is Hand Smart Electrodes Dock
IMPETO MEDICAL
SUDOTEST
In Commercial Distribution

  • 03770025753065 ()
ADSPHD

  • Skin electrical conductance meter
It is used for baby feeding.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
P71055-00
In Commercial Distribution

  • 10044677710555 ()
  • 00044677710558 ()
  • 40044677710556 ()


  • Breast pump, electric
It is used for baby feeding.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
P71053-00
In Commercial Distribution

  • 10044677710531 ()
  • 40044677710532 ()
  • 00044677710534 ()


  • Breast pump, electric
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