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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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ValueStim - 10850689007428

2"x 2" Cloth, Case of 10
COMPASS HEALTH BRANDS CORP.
202-675
Not in Commercial Distribution

  • 10850689007428 ()


  • Transcutaneous electrical stimulation electrode, single-use

STICK-E-PADS - 10850689007381

2"x 3.5" Foam, Case of 10
COMPASS HEALTH BRANDS CORP.
203-681
In Commercial Distribution

  • 10850689007381 ()


  • Transcutaneous electrical stimulation electrode, single-use

PROFIX - 03596010224927

PROFIX STERILE CASE 5 ART INSERTS/CONFORMING
Smith & Nephew, Inc.
71515005
In Commercial Distribution

  • 03596010224927 ()
71515005

  • Device sterilization/disinfection container, reusable

PROFIX - 03596010224910

PROFIX STERILE CASE 4 ART INSERTS/CONFORMING
Smith & Nephew, Inc.
71515004
In Commercial Distribution

  • 03596010224910 ()
71515004

  • Device sterilization/disinfection container, reusable

PROFIX - 03596010224903

PROFIX STERILE CASE 3 FEMORAL/TIBIAL TRIALS
Smith & Nephew, Inc.
71515003
In Commercial Distribution

  • 03596010224903 ()
71515003

  • Device sterilization/disinfection container, reusable

PROFIX - 03596010224897

PROFIX STERILE CASE 2-FEM/TIB CUTTING BLOCKS
Smith & Nephew, Inc.
71515002
In Commercial Distribution

  • 03596010224897 ()
71515002

  • Device sterilization/disinfection container, reusable

ACUMED - 10806378113994

ARH Solutions 2 Case Base Double Level
Acumed LLC
80-3693
In Commercial Distribution

  • 10806378113994 ()


  • General internal orthopaedic fixation system implantation kit

ACUMED - 10806378113987

ARH Solutions 2 Case Base Single Level
Acumed LLC
80-3692
In Commercial Distribution

  • 10806378113987 ()


  • General internal orthopaedic fixation system implantation kit

ACUMED - 10806378099496

3/4-Size Single Level ASCS Case Base
Acumed LLC
80-1700
In Commercial Distribution

  • 10806378099496 ()


  • General internal orthopaedic fixation system implantation kit

ACUMED - 10806378099489

3/4-Size Single Level ASCS Case Lid
Acumed LLC
80-1699
In Commercial Distribution

  • 10806378099489 ()


  • General internal orthopaedic fixation system implantation kit

MD-Max ULIF - 00840019936965

MD-Max™ Triple Lead System Implant Case
PRECISION SPINE, INC.
43-8600-CA
In Commercial Distribution

  • 00840019936965 ()
43-8600-CA

  • Spinal bone screw, non-bioabsorbable
  • Bone-screw internal spinal fixation system rod
  • Spinal bone set screw

MD-Max ULIF - 00840019936934

MD-Max™ Triple Lead System Instrument Case
PRECISION SPINE, INC.
43-8100-CA
In Commercial Distribution

  • 00840019936934 ()
43-8100-CA

  • Internal spinal fixation procedure kit, reusable

SureLOK MIS 3L - 00840019936637

Implant Case 2 BOM (Side Load Rod)
PRECISION SPINE, INC.
63-8700-CA-02
In Commercial Distribution

  • 00840019936637 ()
63-8700-CA-02

  • Bone-screw internal spinal fixation system rod

SureLOK MIS 3L - 00840019936620

Implant Case 2 BOM (Center Load Rod)
PRECISION SPINE, INC.
63-8700-CA-01
In Commercial Distribution

  • 00840019936620 ()
63-8700-CA-01

  • Bone-screw internal spinal fixation system rod

SureLOK MIS 3L - 00840019936613

Implant Case 1 BOM (Side Load Rod)
PRECISION SPINE, INC.
63-8600-CA-02
In Commercial Distribution

  • 00840019936613 ()
63-8600-CA-02

  • Bone-screw internal spinal fixation system rod

SureLOK MIS 3L - 00840019936606

Implant Case 1 BOM (Center Load Rod)
PRECISION SPINE, INC.
63-8600-CA-01
In Commercial Distribution

  • 00840019936606 ()
63-8600-CA-01

  • Bone-screw internal spinal fixation system rod

SureLOK MIS 3L - 00840019936590

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8300-CA-02
In Commercial Distribution

  • 00840019936590 ()
63-8300-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936583

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8300-CA-01
In Commercial Distribution

  • 00840019936583 ()
63-8300-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936576

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8200-CA-02
In Commercial Distribution

  • 00840019936576 ()
63-8200-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936569

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8200-CA-01
In Commercial Distribution

  • 00840019936569 ()
63-8200-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936552

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8100-CA-02
In Commercial Distribution

  • 00840019936552 ()
63-8100-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936545

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8100-CA-01
In Commercial Distribution

  • 00840019936545 ()
63-8100-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Ti Modular - 00840019935685

Reform Ti Tower Screw Implant Case BOM
PRECISION SPINE, INC.
39-BK-0530
In Commercial Distribution

  • 00840019935685 ()
39-BK-0530

  • Orthopaedic surgical procedure kit, non-medicated, reusable

AllCare - 00182921000496

UNIVERSAL PILLOW CASE, 21" x 30", WHITE
ALLCARE, INC
PL100
In Commercial Distribution

  • 10182921000493 ()
  • 00182921000496 ()
PL100

  • Basic pillowcase, reusable

Medline - 00080196169736

ANEROID,HAND HELD,NYLON CASE,HUNTR GRN
MEDLINE INDUSTRIES, INC.
MDS9108
In Commercial Distribution

  • 00080196169736 ()
MDS9108

  • Aneroid manual sphygmomanometer

Medline - 00080196169712

ANEROID,HAND HELD,NYLON CASE,NAVY BLUE
MEDLINE INDUSTRIES, INC.
MDS9106
In Commercial Distribution

  • 00080196169712 ()
MDS9106

  • Aneroid manual sphygmomanometer

Anmuth Medical International - 08403207007803

Mini-Lambotte Osteotome Set of 9 in Case
Anmuth Medical International, LLC
38-654-01
In Commercial Distribution

  • 08403207007803 ()

  • Length: 8 Inch
38-654-01

  • Orthopaedic osteotome

ACUMED - 10806378089893

Acu-Loc® 2 CORE System Case Lid
Acumed LLC
80-1996
In Commercial Distribution

  • 10806378089893 ()


  • General internal orthopaedic fixation system implantation kit

Navigated Instrument System - 00840019970556

S-COMP Reform® POCT Navigated Instrument Case
PRECISION SPINE, INC.
76-SC-0100
In Commercial Distribution

  • 00840019970556 ()
76-SC-0100

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ACUMED - 10806378076220

Foot & Ankle Cong Plt Instr Module Case
Acumed LLC
PL-FAM31
In Commercial Distribution

  • 10806378076220 ()


  • Orthopaedic fixation plate, non-bioabsorbable

ACUMED - 10806378076190

Open Plate Module for Foot & Ankle Case
Acumed LLC
PL-FAM13
In Commercial Distribution

  • 10806378076190 ()


  • Orthopaedic fixation plate, non-bioabsorbable

ShurFit MALIF System - 00840019925495

ShurFit™ MALIF Instrument Case # 2 (Empty)
PRECISION SPINE, INC.
50-0015
In Commercial Distribution

  • 00840019925495 ()
50-0015

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ShurFit MALIF System - 00840019925488

ShurFit™ MALIF Instrument Case # 1 (Empty)
PRECISION SPINE, INC.
50-0014
In Commercial Distribution

  • 00840019925488 ()
50-0014

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924986

ShurFit™ ALIF Implant Case # 3 (Empty)
PRECISION SPINE, INC.
50-0021
In Commercial Distribution

  • 00840019924986 ()
50-0021

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924979

ShurFit™ ALIF Implant Case # 2 (Empty)
PRECISION SPINE, INC.
50-0020
In Commercial Distribution

  • 00840019924979 ()
50-0020

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924962

ShurFit™ ALIF Implant Case # 1 (Empty)
PRECISION SPINE, INC.
50-0019
In Commercial Distribution

  • 00840019924962 ()
50-0019

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924955

ShurFit™ ALIF Instrument Case # 3 (Empty)
PRECISION SPINE, INC.
50-0012
In Commercial Distribution

  • 00840019924955 ()
50-0012

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924948

ShurFit™ ALIF Instrument Case # 2 (Empty)
PRECISION SPINE, INC.
50-0011
In Commercial Distribution

  • 00840019924948 ()
50-0011

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924931

ShurFit™ ALIF Instrument Case # 1 (Empty)
PRECISION SPINE, INC.
50-0010
In Commercial Distribution

  • 00840019924931 ()
50-0010

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923835

PLIF/TLIF/TPLIF Instrument Case 2 (Empty)
PRECISION SPINE, INC.
50-0024
In Commercial Distribution

  • 00840019923835 ()
50-0024

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923828

PLIF/TLIF/TPLIF Instrument Case 1 (Empty)
PRECISION SPINE, INC.
50-0023
In Commercial Distribution

  • 00840019923828 ()
50-0023

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ShurFit ACIF 2C - 00840019921473

ACIF 2C Instrument Case - Expanded + Double Wide
PRECISION SPINE, INC.
62-SC-0102
In Commercial Distribution

  • 00840019921473 ()
62-SC-0102

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK Mini Posterior Cervical/Upper Thoracic System - 00840019920759

SureLOK™ PC System Implant Case (Empty)
PRECISION SPINE, INC.
50-0006
In Commercial Distribution

  • 00840019920759 ()
50-0006

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019917223

Implant Sterilization Case Assembly (All Caddies Included)
PRECISION SPINE, INC.
37-SC-0110
In Commercial Distribution

  • 00840019917223 ()
37-SC-0110

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Max ULIF - 00840019926218

MD-Max™ Pedicle Screw System Case - Empty
PRECISION SPINE, INC.
43-8700
In Commercial Distribution

  • 00840019926218 ()
43-8700

  • Instrument tray, reusable

MD-Max ULIF - 00840019926164

MD-Max™ ULIF Retractor Instrument Case - Empty
PRECISION SPINE, INC.
43-8050
In Commercial Distribution

  • 00840019926164 ()
43-8050

  • Instrument tray, reusable

CHS - 03596010173669

AMBI/CLASSIC COMPRESSION HIP SCREW STER CASE
Smith & Nephew, Inc.
71115090
In Commercial Distribution

  • 03596010173669 ()
71115090

  • Device sterilization/disinfection container, reusable

Reform Pedicle Screw System - 00840019929080

Reform® Modular Pedicle Screw Implant Case
PRECISION SPINE, INC.
39-SC-0500
In Commercial Distribution

  • 00840019929080 ()
39-SC-0500

  • Orthopaedic surgical procedure kit, non-medicated, reusable

GENESIS II - 03596010420978

GENESIS II FINISHING INSTRUMENT CASE SIZES 1-2
Smith & Nephew, Inc.
71440770
In Commercial Distribution

  • 03596010420978 ()
71440770

  • Device sterilization/disinfection container, reusable

GENESIS II - 03596010397928

GENESIS II FEMORAL INSTRUMENT CASE SIZES 3-6
Smith & Nephew, Inc.
71440760
In Commercial Distribution

  • 03596010397928 ()
71440760

  • Device sterilization/disinfection container, reusable
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