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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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TAPERLOC® LATERALIZED OFFSET - 00880304010987

No Description
Biomet Orthopedics, LLC
31-478048
In Commercial Distribution

  • 00880304010987 ()
31-478048

  • Femoral head prosthesis trial

TAPERLOC® LATERALIZED OFFSET - 00880304010970

No Description
Biomet Orthopedics, LLC
31-478047
In Commercial Distribution

  • 00880304010970 ()
31-478047

  • Femoral head prosthesis trial

Mission Urinalysis Reagent Strips - 00682607000524

Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH)
Acon Laboratories, Inc.
U031-041
In Commercial Distribution

  • 00682607000524 ()
  • 00682607000883 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607000517

Mission Urinalysis Reagent Strip (GLU/PRO/PH/BLO)
Acon Laboratories, Inc.
U031-041
In Commercial Distribution

  • 00682607000517 ()
  • 00682607000876 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

MALLORY/HEAD CALCAR HIP SYSTEM - 00880304010918

No Description
Biomet Orthopedics, LLC
108139
In Commercial Distribution

  • 00880304010918 ()

  • 45E SIZE TYPE1 TAPER
108139

  • Coated femoral stem prosthesis, modular

Gentle Threads - 00880304010901

No Description
Biomet Orthopedics, LLC
905602
In Commercial Distribution

  • 00880304010901 ()

  • 7 MM 30 MM FULL THREAD
905602

  • Bioabsorbable orthopaedic bone screw

Mission Urinalysis Reagent Strips - 00682607000487

Mission Urinalysis Reagent Strip (BLO/NIT/LEU)
Acon Laboratories, Inc.
U031-031
In Commercial Distribution

  • 00682607000487 ()
  • 00682607000845 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

OSS™ Orthopedic Salvage System - 00880304010888

No Description
Biomet Orthopedics, LLC
150411
In Commercial Distribution

  • 00880304010888 ()

  • Standard 14 mm
150411

  • Tibial insert

Mission Urinalysis Reagent Strips - 00682607000463

Mission Urinalysis Reagent Strips (GLU/KET/PRO)
Acon Laboratories, Inc.
U031-031
In Commercial Distribution

  • 00682607000463 ()
  • 00682607000821 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

BIO-MODULAR SHOULDER SYSTEM - 00880304010864

No Description
Biomet Orthopedics, LLC
113764
In Commercial Distribution

  • 00880304010864 ()

  • 44MM HEAD Ø 17MM HEIGHT
113764

  • Stem-fixed metallic humeral head prosthesis

Mission Urinalysis Reagent Strips - 00682607000449

Mission Urinalysis Reagent Strips (ALB/CRE)
Acon Laboratories, Inc.
U031-021
In Commercial Distribution

  • 00682607000449 ()
  • 00682607000807 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607000432

Mission Urinalysis Reagent Strips (SG/PH)
Acon Laboratories, Inc.
U031-021
In Commercial Distribution

  • 00682607000432 ()
  • 00682607000791 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607000425

Mission Urinalysis Reagent Strips (BIL/URO)
Acon Laboratories, Inc.
U031-021
In Commercial Distribution

  • 00682607000425 ()
  • 00682607000784 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607000418

Mission Urinalysis Reagent Strips (BLO/LEU)
Acon Laboratories, Inc.
U031-021
In Commercial Distribution

  • 00682607000418 ()
  • 00682607000777 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

RINGLOC HIP SYSTEM - 00880304010796

No Description
Biomet Orthopedics, LLC
11-105862
In Commercial Distribution

  • 00880304010796 ()

  • 28MM HEAD SIZE 22 LINER SIZE
11-105862

  • Non-constrained polyethylene acetabular liner

Mission Urinalysis Reagent Strips - 00682607000395

Mission Urinalysis Reagent Strips (GLU/KET)
Acon Laboratories, Inc.
U031-021
In Commercial Distribution

  • 00682607000395 ()
  • 00682607000753 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Maxim Knee System - 00880304010772

No Description
Biomet Orthopedics, LLC
11-146770
In Commercial Distribution

  • 00880304010772 ()

  • 10MM 79/83MM
11-146770

  • Tibial insert

Mission Urinalysis Reagent Strips - 00682607000371

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

  • 00682607000371 ()
  • 00682607000739 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical

BI-METRIC REVISION HIP SYSTEM - 00880304010758

No Description
Biomet Orthopedics, LLC
162350
In Commercial Distribution

  • 00880304010758 ()

  • 9 SIZE 250 MM TYPE1 TAPER
162350

  • Press-fit femoral stem prosthesis

Mission Urinalysis Reagent Strips - 00682607000357

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

  • 00682607000357 ()
  • 00682607000715 ()


  • Urine glucose IVD, kit, rapid colorimetric, clinical

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

BI-ANGULAR SYSTEM - 00880304009622

No Description
Biomet Orthopedics, LLC
114022
In Commercial Distribution

  • 00880304009622 ()

  • 40MM Ø 15MM HEIGHT
114022

  • Stem-fixed metallic humeral head prosthesis

N/A - 00681490993548

DRILL BIT 9098040 FACET SCREW
MEDTRONIC SOFAMOR DANEK, INC.
9098040
In Commercial Distribution

  • 00681490993548 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

BMP SLEEVE GRIP CRIMPER - 00880304009608

No Description
Biomet Orthopedics, LLC
498003
In Commercial Distribution

  • 00880304009608 ()
498003

  • Orthopaedic wire crimper

Medtronic Reusable Instruments - 00681490993258

2MM DOWNBIT PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560569
In Commercial Distribution

  • 00681490993258 ()


  • Orthopaedic joint/limb rongeur

Medtronic Reusable Instruments - 00681490993241

MICROPITUITARY X9560567 2MM UPBTNG TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560567
In Commercial Distribution

  • 00681490993241 ()


  • Orthopaedic joint/limb rongeur

Maxim Knee System - 00880304009561

No Description
Biomet Orthopedics, LLC
11-146556
In Commercial Distribution

  • 00880304009561 ()

  • 16MM 71/75MM
11-146556

  • Tibial insert

Medtronic Reusable Instruments - 00681490993210

2MM UPBITING PITUITARY W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X9560564
In Commercial Distribution

  • 00681490993210 ()


  • Orthopaedic joint/limb rongeur

RING-LOC(R) ACETABULAR TRIAL - 00880304009523

No Description
Biomet Orthopedics, LLC
433756
In Commercial Distribution

  • 00880304009523 ()
433756

  • Acetabulum prosthesis trial, prefabricated, reusable

Medtronic Reusable Instruments - 00681490993180

2MM BAYONET KERRISON, 90
MEDTRONIC SOFAMOR DANEK, INC.
X9560603
In Commercial Distribution

  • 00681490993180 ()


  • Bone curette, reusable

RING-LOC(R) ACETABULAR TRIAL - 00880304009509

No Description
Biomet Orthopedics, LLC
433764
In Commercial Distribution

  • 00880304009509 ()
433764

  • Acetabulum prosthesis trial, prefabricated, reusable
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