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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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No Description
Biomet Orthopedics, LLC
32-347151
In Commercial Distribution

  • 00880304327764 ()
32-347151

  • Surgical drill guide, reusable
CALLCORD,2 IN,800,JERON WIRED
CURBELL MEDICAL PRODUCTS, INC.
CC02-020
In Commercial Distribution

  • 00840828125659 ()
5704

  • Fixed call button
800 P37,IN,2L,NO TALKBACK
CURBELL MEDICAL PRODUCTS, INC.
BIC-19D0-E01-8
In Commercial Distribution

  • 00840828123822 ()
3907

  • Electrical mains power extension cable
800 P37,IN,BE,1L,STD
CURBELL MEDICAL PRODUCTS, INC.
BIC-19D0-E00-8
In Commercial Distribution

  • 00840828123815 ()
3906

  • Electrical mains power extension cable
800 S37,IN,2L,NO TALKBACK
CURBELL MEDICAL PRODUCTS, INC.
BIC-19D0-A01-8
In Commercial Distribution

  • 00840828123808 ()
3905

  • Electrical mains power extension cable
800 S37,IN,BE,1L,STD
CURBELL MEDICAL PRODUCTS, INC.
BIC-19D0-A00-8
In Commercial Distribution

  • 00840828123792 ()
3904

  • Electrical mains power extension cable
w/ 4.4L Reservoir
BELMONT INSTRUMENT CORPORATION
902-00037
In Commercial Distribution

  • 00896128002213 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices.
TECRES SPA
71271610
In Commercial Distribution

  • 08031497002330 ()


  • Orthopaedic cement/bone filler dispensing gun
The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Oculo-Plastik Inc
21-416V
Not in Commercial Distribution

  • M87221416V95 ()

  • Outer Diameter: 24 Millimeter


  • Symblepharon ring, synthetic
The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Oculo-Plastik Inc
21-414V
Not in Commercial Distribution

  • M87221414V93 ()

  • Outer Diameter: 22 Millimeter


  • Symblepharon ring, synthetic
The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Oculo-Plastik Inc
21-412V
Not in Commercial Distribution

  • M87221412V91 ()

  • Outer Diameter: 20 Millimeter


  • Symblepharon ring, synthetic
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-124V
Not in Commercial Distribution

  • M87219124V98 ()

  • Depth: 1.8 Millimeter
  • Width: 25.5 Millimeter
  • Length: 26 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-122V
Not in Commercial Distribution

  • M87219122V96 ()

  • Depth: 1.8 Millimeter
  • Width: 23.5 Millimeter
  • Length: 24 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-114V
Not in Commercial Distribution

  • M87219114V97 ()

  • Depth: 1.8 Millimeter
  • Width: 25 Millimeter
  • Length: 27 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-112V
Not in Commercial Distribution

  • M87219112V95 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 25 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094V
Not in Commercial Distribution

  • M87219094V9 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 28 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-092V
Not in Commercial Distribution

  • M87219092V9 ()

  • Depth: 1.8 Millimeter
  • Width: 21 Millimeter
  • Length: 25.5 Millimeter


  • Ophthalmic conformer
HOSE,O2,DISS/DISS 28 IN
PARKER-HANNIFIN CORPORATION
8002.33
In Commercial Distribution

  • 00816711022930 ()
8002.33

  • Oxygen low pressure hose
HOSE,O2,DISS/DISS 6 IN
PARKER-HANNIFIN CORPORATION
8000.5
In Commercial Distribution

  • 00816711023760 ()


  • Oxygen low pressure hose
HOSE,O2,DISS/DISS 20 IN
PARKER-HANNIFIN CORPORATION
8001.67
In Commercial Distribution

  • 00816711022213 ()
8001.67

  • Oxygen low pressure hose
No Description
PARKS MEDICAL ELECTRONICS, INC.
915-BL 24V 901C
In Commercial Distribution

  • 00816787024104 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
915-BL 24V 800C
In Commercial Distribution

  • 00816787024098 ()


  • Laser Doppler blood flowmeter
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094V
Not in Commercial Distribution


  • Length: 28 Millimeter
  • Width: 23 Millimeter
  • Depth: 1.8 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-092V
Not in Commercial Distribution


  • Length: 25.5 Millimeter
  • Width: 21 Millimeter
  • Depth: 1.8 Millimeter


  • Ophthalmic conformer
No Description
STERITEC PRODUCT MFG. CO., INC.
61301606669
Not in Commercial Distribution

  • 10814434020445 ()
  • 00814434020448 ()
  • 20814434020442 ()
  • 30814434020449 ()
61301606669

  • Chemical/physical sterilization process indicator
No Description
WALK VASCULAR L.L.C.
WVTUB1
Not in Commercial Distribution

  • B139WVTUB12 ()
  • B139WVTUB11 ()


  • Surgical suction system collection container, single-use
No Description
WALK VASCULAR L.L.C.
WVCART
Not in Commercial Distribution

  • B139WVCART2 ()
  • B139WVCART0 ()


  • Medical device integration rack
No Description
WALK VASCULAR L.L.C.
WV1500A
Not in Commercial Distribution

  • B139WV1500A2 ()
  • B139WV1500A1 ()


  • Surgical suction system collection container, single-use
POZZ COBALT CLASP WIRE IN SPOOLS 1.2MM
AMERICAN TOOTH INDUSTRIES
015-410/1.2
In Commercial Distribution

  • D772015410120 ()


  • Orthodontic wire
POZZI COBALT CLASP WIRE IN SPOOLS 1.1MM
AMERICAN TOOTH INDUSTRIES
015-410/1.1
In Commercial Distribution

  • D772015410110 ()


  • Orthodontic wire
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