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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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Mission Urinalysis Reagent Strips - 00682607000340

Mission Urinalysis Reagent Strips (PH)
Acon Laboratories, Inc.
U031-011
In Commercial Distribution

  • 00682607000340 ()
  • 00682607000708 ()


  • Urine pH IVD, kit, rapid colorimetric, clinical

AGC Tradition Knee System - 00880304009875

No Description
Biomet Orthopedics, LLC
151012
In Commercial Distribution

  • 00880304009875 ()

  • 14 MM 71/75 MM
151012

  • Tibial insert

On Call Pro Blood Glucose Test Strips - 00682607000296

Blood Glucose Test Strips, vial of 50 strips
Acon Laboratories, Inc.
G135-10L
In Commercial Distribution

  • 00682607000296 ()
  • 00682607000128 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

RINGLOC HIP SYSTEM - 00880304009851

No Description
Biomet Orthopedics, LLC
135254
In Commercial Distribution

  • 00880304009851 ()

  • 54 MM 24 LINER SIZE
135254

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009844

No Description
Biomet Orthopedics, LLC
135246
In Commercial Distribution

  • 00880304009844 ()

  • 46 MM 22 LINER SIZE
135246

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009837

No Description
Biomet Orthopedics, LLC
135268
In Commercial Distribution

  • 00880304009837 ()

  • 68 MM 27 LINER SIZE
135268

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009820

No Description
Biomet Orthopedics, LLC
135270
In Commercial Distribution

  • 00880304009820 ()

  • 70 MM 28 LINER SIZE
135270

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009813

No Description
Biomet Orthopedics, LLC
135266
In Commercial Distribution

  • 00880304009813 ()

  • 66 MM 27 LINER SIZE
135266

  • Acetabular shell

On Call Express Blood Glucose Test Strips - 00682607000098

Blood Glucose Test Strips, vial of 50 strips
Acon Laboratories, Inc.
G135-10D
In Commercial Distribution

  • 00682607000098 ()
  • 00682607000111 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

RINGLOC HIP SYSTEM - 00880304009790

No Description
Biomet Orthopedics, LLC
135262
In Commercial Distribution

  • 00880304009790 ()

  • 62 MM 26 LINER SIZE
135262

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009783

No Description
Biomet Orthopedics, LLC
135260
In Commercial Distribution

  • 00880304009783 ()

  • 60 MM 25 LINER SIZE
135260

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009776

No Description
Biomet Orthopedics, LLC
135258
In Commercial Distribution

  • 00880304009776 ()

  • 58 MM 25 LINER SIZE
135258

  • Acetabular shell

RINGLOC HIP SYSTEM - 00880304009769

No Description
Biomet Orthopedics, LLC
135248
In Commercial Distribution

  • 00880304009769 ()

  • 48 MM 22 LINER SIZE
135248

  • Acetabular shell

MALLORY/HEAD CALCAR HIP SYSTEM - 00880304009752

No Description
Biomet Orthopedics, LLC
11-108277
In Commercial Distribution

  • 00880304009752 ()

  • 17 SIZE 250 MM
11-108277

  • Acetabular shell

INTRAMEDULLARY BONE SAW - 00880304009745

No Description
Biomet Orthopedics, LLC
475675
In Commercial Distribution

  • 00880304009745 ()
475675

  • Bone file/rasp, manual, reusable

Biomet® Knee System - 00880304009738

No Description
Biomet Orthopedics, LLC
141205
In Commercial Distribution

  • 00880304009738 ()
141205

  • Uncoated knee tibia prosthesis, metallic

AGC Tradition Knee System - 00880304009721

No Description
Biomet Orthopedics, LLC
151014
In Commercial Distribution

  • 00880304009721 ()

  • 18 MM 71/75 MM
151014

  • Tibial insert

AGC Tradition Knee System - 00880304009714

No Description
Biomet Orthopedics, LLC
151009
In Commercial Distribution

  • 00880304009714 ()

  • 18 MM 63/67 MM
151009

  • Tibial insert

N/A - 00681490993616

DRIVER 9098061 HEX STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
9098061
In Commercial Distribution

  • 00681490993616 ()


  • Surgical screwdriver, reusable

BIO-MODULAR SHOULDER SYSTEM - 00880304009639

No Description
Biomet Orthopedics, LLC
11-113800
In Commercial Distribution

  • 00880304009639 ()

  • 7 MM 190 MM
11-113800

  • Coated shoulder humeral stem prosthesis
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