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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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Link Embrace Shoulder System - Instruments - 04026575278947

Humeral stem prosthesis trial, reusable - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
631-075/24
In Commercial Distribution

  • 04026575278947 ()


  • Humeral stem prosthesis trial, reusable

Link Embrace Shoulder System - Instruments - 04026575278831

Orthopaedic broach - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
630-100/24
In Commercial Distribution

  • 04026575278831 ()


  • Orthopaedic broach

LINK Endo-Model EVO Knee System - 04026575277742

No Description
WALDEMAR LINK GmbH & Co. KG
15-5305/24
In Commercial Distribution

  • 04026575277742 ()


  • Knee femur stem prosthesis

LINK Endo-Model EVO Knee System - 04026575274697

Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security screw (EVO)
WALDEMAR LINK GmbH & Co. KG
15-0037/24
In Commercial Distribution

  • 04026575274697 ()


  • Rotating hinged total knee prosthesis

LinkBio Instrument - 00810022403358

Broach, Tibial Cone, L Half +2mm
Link Bio Corp
87-1903/24
In Commercial Distribution

  • 00810022403358 ()


  • Orthopaedic broach

Portex - 20351688069501

No Description
ICU MEDICAL, INC.
A3403-22/24
In Commercial Distribution

  • 30351688069508 ()
  • 20351688069501 ()


  • Epidural anaesthesia set, medicated

Portex - 20351688077735

No Description
ICU MEDICAL, INC.
A3879-22/24
In Commercial Distribution

  • 30351688077732 ()
  • 20351688077735 ()


  • Epidural anaesthesia set, medicated

IFAK - B54133311080

Individual First Aid Kit
FARETEC, INC.
IFAK 24
In Commercial Distribution

  • B54133311080 ()
3331108

  • First aid kit, non-medicated, single-use

Libertas - 00810008127452

Taper Uncemented Femoral Stem Size 24/132° Mini TR Lateral Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STUC-32/24
In Commercial Distribution

  • 00810008127452 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008126837

Taper Uncemented Femoral Stem Size 24/128° Mini TR Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STTC-28/24
In Commercial Distribution

  • 00810008126837 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008126707

Taper Uncemented Femoral Stem Size 24/128° Mini TR
MAXX ORTHOPEDICS, INC.
MO-STRC-28/24
In Commercial Distribution

  • 00810008126707 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008124192

Taper Uncemented Femoral Stem Size 24/132° Lateral Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STOC-32/24
In Commercial Distribution

  • 00810008124192 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008123881

Taper Uncemented Femoral Stem Size 24/132° Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STNC-32/24
In Commercial Distribution

  • 00810008123881 ()


  • Metal-on-polyethylene total hip prosthesis

Directa Temporary Polycarbonate Crowns - 17310236093159

No Description
Directa AB
OP 24
In Commercial Distribution

  • 17310236093159 ()
609315

  • Preformed dental crown, temporary

ALLSHENG - 06975141980112

No Description
HANGZHOU ALLSHENG INSTRUMENTS CO.,LTD.
Auto-Pure 24
In Commercial Distribution

  • 06975141980112 ()


  • Nucleic acid sample preparation instrument IVD

Libertas - 00810008127322

Taper Uncemented Femoral Stem Size 24/132° Mini TR Lateral
MAXX ORTHOPEDICS, INC.
MO-STSC-32/24
In Commercial Distribution

  • 00810008127322 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008127148

Taper Uncemented Femoral Stem Size 24/132° Mini TR Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STTC-32/24
In Commercial Distribution

  • 00810008127148 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008127018

Taper Uncemented Femoral Stem Size 24/132° Mini TR
MAXX ORTHOPEDICS, INC.
MO-STRC-32/24
In Commercial Distribution

  • 00810008127018 ()


  • Press-fit femoral stem prosthesis

Libertas - 00810008123577

Taper Uncemented Femoral Stem Size 24/128° Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STNC-28/24
In Commercial Distribution

  • 00810008123577 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008121931

Centralizer Universal
MAXX ORTHOPEDICS, INC.
MO-SCAG-20/24
In Commercial Distribution

  • 00810008121931 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008129616

TS Uncemented Femoral Stem Size 24/132° Lateral Collared
MAXX ORTHOPEDICS, INC.
MO-SFDC-32/24
In Commercial Distribution

  • 00810008129616 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008129258

TS Uncemented Femoral Stem Size 24/132° Collared
MAXX ORTHOPEDICS, INC.
MO-SFCC-32/24
In Commercial Distribution

  • 00810008129258 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008128893

TS Uncemented Femoral Stem Size 24/128° Collared
MAXX ORTHOPEDICS, INC.
MO-SFCC-28/24
In Commercial Distribution

  • 00810008128893 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008124062

Taper Uncemented Femoral Stem Size 24/132° Lateral
MAXX ORTHOPEDICS, INC.
MO-STFC-32/24
In Commercial Distribution

  • 00810008124062 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008123751

Taper Uncemented Femoral Stem Size 24/132° Standard
MAXX ORTHOPEDICS, INC.
MO-STEC-32/24
In Commercial Distribution

  • 00810008123751 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008123447

Taper Uncemented Femoral Stem Size 24/128° Standard
MAXX ORTHOPEDICS, INC.
MO-STEC-28/24
In Commercial Distribution

  • 00810008123447 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008129432

TS Uncemented Femoral Stem Size 24/132° Lateral
MAXX ORTHOPEDICS, INC.
MO-SFBC-32/24
In Commercial Distribution

  • 00810008129432 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008129074

TS Uncemented Femoral Stem Size 24/132°
MAXX ORTHOPEDICS, INC.
MO-SFAC-32/24
In Commercial Distribution

  • 00810008129074 ()


  • Metal-on-polyethylene total hip prosthesis

Libertas - 00810008128718

TS Uncemented Femoral Stem Size 24/128°
MAXX ORTHOPEDICS, INC.
MO-SFAC-28/24
In Commercial Distribution

  • 00810008128718 ()


  • Metal-on-polyethylene total hip prosthesis

Anti-Thyroglobulin (Anti-Tg) ELISA - 04048474041101

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4110
In Commercial Distribution

  • 04048474041101 ()
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

CPAP Filter - 00850035116470

Resvent iBreeze Disposable CPAP Filter - 24/pk
SUNSET HEALTHCARE SOLUTIONS, INC.
ASNU001CF9901-24
In Commercial Distribution

  • 00850035116470 ()


  • CPAP/BPAP unit ambient air filter, single-use

MH - 00850018327671

24” Bouffant Cap, Blue, SBPP, Latex Free
MAZZA HEALTHCARE LLC
3010-24
In Commercial Distribution

  • 10850018327678 ()
  • 00850018327671 ()
  • 20850018327675 ()


  • Surgical cap, single-use

N.A. - J011871024000

Standard Band, Tooth 47-46/36-37, Size 24
DENTAURUM GmbH & Co.KG
871-024-00
In Commercial Distribution

  • J011871024000 ()
  • J011871024001 ()


  • Orthodontic metal band

N.A. - J011870024000

Standard Band, Tooth 17-16/26-27, Size 24
DENTAURUM GmbH & Co.KG
870-024-00
In Commercial Distribution

  • J011870024000 ()
  • J011870024001 ()


  • Orthodontic metal band

N.A. - J011861124000

Standard Band, Tooth 45-44/34-35, Size 24
DENTAURUM GmbH & Co.KG
861-124-00
In Commercial Distribution

  • J011861124000 ()
  • J011861124001 ()


  • Orthodontic metal band

N.A. - J011860124000

Standard Band, Tooth 15-14/24-25, Size 24
DENTAURUM GmbH & Co.KG
860-124-00
In Commercial Distribution

  • J011860124000 ()
  • J011860124001 ()


  • Orthodontic metal band

EZ Mold Singles 24 Pk Forest Green - 00850047788290

EZ Mold Singles 24 Pk Forest Green
Westone Laboratories, Inc.
NA
In Commercial Distribution

  • 00850047788290 ()
10341

  • Earmould impression material

MediFlo - 00850007185695

MEDIFLO 270ML VOL/ 175ML HR 24/CS
NDC HOMECARE LLC
MDE271750
In Commercial Distribution

  • 10850007185692 ()
  • 00850007185695 ()
MDE271750

  • Elastomeric infusion pump system

MediFlo - 00850007185312

MEDIFLO 200ML VOL/ 100ML HR 24/CS
NDC HOMECARE LLC
MDE200100
In Commercial Distribution

  • 10850007185319 ()
  • 00850007185312 ()
MDE200100

  • Elastomeric infusion pump system

MediFlo - 00850007185305

MEDIFLO 300ML VOL/ 6ML HR 24/CS
NDC HOMECARE LLC
MDC300060
In Commercial Distribution

  • 10850007185302 ()
  • 00850007185305 ()
MDC300060

  • Elastomeric infusion pump system
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