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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INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-20-8
Not in Commercial Distribution

34-A30-20-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-20-4
Not in Commercial Distribution

34-A30-20-4

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-20-12
Not in Commercial Distribution

34-A30-20-12

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-18-8
Not in Commercial Distribution

34-A30-18-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-18-4
Not in Commercial Distribution

34-A30-18-4

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-18-12
Not in Commercial Distribution

34-A30-18-12

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-16-8
Not in Commercial Distribution

34-A30-16-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-16-4
Not in Commercial Distribution

34-A30-16-4

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-16-12
Not in Commercial Distribution

34-A30-16-12

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-14-8
Not in Commercial Distribution

34-A30-14-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-14-4
Not in Commercial Distribution

34-A30-14-4

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-14-12
Not in Commercial Distribution

34-A30-14-12

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-12-8
Not in Commercial Distribution

34-A30-12-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-12-4
Not in Commercial Distribution

34-A30-12-4

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-12-12
Not in Commercial Distribution

34-A30-12-12

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-10-8
Not in Commercial Distribution

34-A30-10-8

  • Vertebral body prosthesis
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
34-A30-10-4
Not in Commercial Distribution

34-A30-10-4

  • Vertebral body prosthesis
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
TAT-80T
In Commercial Distribution

  • 06945087580011 ()


  • Ophthalmic tonometer, manual
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
TAT-80R
In Commercial Distribution

  • 06945087580004 ()


  • Ophthalmic tonometer, manual
Tonometer is indicated for Intraocular Pressure (IOP) measurement .
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
T170(T)
In Commercial Distribution

  • 06945087517024 ()


  • Ophthalmic tonometer, manual
Tonometer is indicated for Intraocular Pressure (IOP) measurement .
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
T170(R)
In Commercial Distribution

  • 06945087517017 ()


  • Ophthalmic tonometer, manual
Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®
Fistula Solution Corporation
00860013000394
In Commercial Distribution

  • 00860013000394 ()
00860013000394

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000318
In Commercial Distribution

  • 10860013000315 ()
  • 00860013000318 ()
00860013000318

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000325
In Commercial Distribution

  • 00860013000325 ()
  • 10860013000322 ()
00860013000325

  • Ostomy convexity insert
No Description
Fistula Solution Corporation
00860013000301
In Commercial Distribution

  • 00860013000301 ()
  • 10860013000308 ()
00860013000301

  • Ostomy convexity insert
ESL-Emerald-TN
U.S. OPHTHALMIC, L.L.C.
ESL-Emerald-TN
In Commercial Distribution

  • 00851158007683 ()


  • Ophthalmic tonometer, manual
No Description
U.S. OPHTHALMIC, L.L.C.
TN-180B
In Commercial Distribution

  • 00851158007119 ()


  • Ophthalmic tonometer, manual
No Description
U.S. OPHTHALMIC, L.L.C.
TN-150B
In Commercial Distribution

  • 00851158007102 ()


  • Ophthalmic tonometer, manual
The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.
ZIEN MEDICAL TECHNOLOGIES, INC.
CATS-D
In Commercial Distribution

  • 00860412001558 ()
  • 00860412001541 ()
CATS-D

  • Ophthalmic tonometer, manual
The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism that is optimized to work with the GAT's operating system to reduce errors in the measurement due to patient anatomical variation. This is used to measure intraocular pressure by applying a known force on the globe of the eye and measuring intraocular tension by applanation. Tonometer prisms are assembled onto a GAT as a patient contacting component that is then utilized by the GAT to assess intraocular pressure.
ZIEN MEDICAL TECHNOLOGIES, INC.
CATS-R
In Commercial Distribution

  • 00860412001510 ()


  • Ophthalmic tonometer, manual
IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.
Trevi Technology, Inc.
AT
In Commercial Distribution

  • 00869228000441 ()


  • Ophthalmic tonometer, manual
No Description
KEELER LIMITED
2414-P-5001
In Commercial Distribution

  • 05055272716529 ()


  • Ophthalmic tonometer, manual
No Description
KEELER LIMITED
2414-P-7039
In Commercial Distribution

  • 05055272718042 ()


  • Ophthalmic tonometer, manual
No Description
KEELER LIMITED
2414-P-2030
In Commercial Distribution

  • 05055272712194 ()


  • Ophthalmic tonometer, manual
No Description
KEELER LIMITED
2414-P-2040
In Commercial Distribution

  • 05055272711722 ()


  • Ophthalmic tonometer, manual
Schiotz tonometer with inclined scale, manufactured and certified by Gulden Ophthalmic, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights
AMBLER SURGICAL CORP.
5754E
In Commercial Distribution

  • 00190660156084 ()
5754E

  • Ophthalmic tonometer, manual
Schiotz tonometer weight - 7.5 gram
AMBLER SURGICAL CORP.
5759E
In Commercial Distribution

  • 00190660156077 ()
5759E

  • Ophthalmic tonometer, manual
Schiotz tonometer weight - 5.5 gram, must send entire unit in for service when ordering this replacement part, service charge included in price listed
AMBLER SURGICAL CORP.
5758E
In Commercial Distribution

  • 00190660156060 ()
5758E

  • Ophthalmic tonometer, manual
Schiotz tonometer weight - 15 gram
AMBLER SURGICAL CORP.
5761E
In Commercial Distribution

  • 00190660156053 ()
5761E

  • Ophthalmic tonometer, manual
Schiotz tonometer weight - 10 gram
AMBLER SURGICAL CORP.
5760E
In Commercial Distribution

  • 00190660156046 ()
5760E

  • Ophthalmic tonometer, manual
Schiotz tonometer replacement transportation case
AMBLER SURGICAL CORP.
5762E
In Commercial Distribution

  • 00190660156039 ()
5762E

  • Ophthalmic tonometer, manual
Allen-Schiotz tonometer with Plunger Retractor and inclined scale, manufactured and certified by Gulden Ophthalmics, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights
AMBLER SURGICAL CORP.
5757E
In Commercial Distribution

  • 00190660156022 ()
5757E

  • Ophthalmic tonometer, manual
APPLANATION TONOMETER
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
TONOMETER A900
In Commercial Distribution

  • 08056098470517 ()
102002200.S

  • Ophthalmic tonometer, manual
APPLANATION TONOMETER
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
TONOMETER F900
In Commercial Distribution

  • 08056098470425 ()
102002100.S

  • Ophthalmic tonometer, manual
No Description
KATENA PRODUCTS, INC.
K 9-8500
In Commercial Distribution

  • 00841668112168 ()
K 9-8500

  • Ophthalmic tonometer, manual
No Description
TAKAGI SEIKO CO.,LTD.
AT-1
In Commercial Distribution

  • 04560323648564 ()


  • Ophthalmic tonometer, manual
No Description
OCULAR INSTRUMENTS, INC.
OGBT-30-50
In Commercial Distribution

  • 00630238101721 ()
  • 00630238101974 ()


  • Ophthalmic tonometer, manual
No Description
OCULAR INSTRUMENTS, INC.
OKBT-20-30
In Commercial Distribution

  • 00630238099790 ()
  • 00630238099844 ()


  • Ophthalmic tonometer, manual
No Description
OCULAR INSTRUMENTS, INC.
OBBT
In Commercial Distribution

  • 00630238067508 ()
  • 00630238067461 ()


  • Ophthalmic tonometer, manual
No Description
OCULAR INSTRUMENTS, INC.
OBVT
In Commercial Distribution

  • 00630238066426 ()
  • 00630238066440 ()


  • Ophthalmic tonometer, manual
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