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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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Hu-Friedy MFG Co., LLC - 10889950025250

NEVI SCALER ANTERIOR D/E #7 Hdl
HU-FRIEDY MFG. CO., LLC
SCNEVI17
In Commercial Distribution

  • 10889950025250 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950025243

NEVI Scaler Anterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI1
In Commercial Distribution

  • 10889950025243 ()


  • Manual dental scaler, reusable

Responsive Respiratory, Inc. - 00851440007407

Single D/E Oxygen Cylinder Wheelchair Bracket
RESPONSIVE RESPIRATORY, INC.
150-0110
In Commercial Distribution

  • 00851440007407 ()


  • Wheelchair medical gas supply holder

Responsive Respiratory, Inc. - 00851440007124

D/E Dual Oxygen Cylinder Wheelchair Case
RESPONSIVE RESPIRATORY, INC.
150-1162
In Commercial Distribution

  • 00851440007124 ()


  • Gas cylinder holder

Responsive Respiratory, Inc. - 00851440007834

Single D/E Oxygen Cylinder Wheelchair Bracket
RESPONSIVE RESPIRATORY, INC.
150-0110
In Commercial Distribution

  • 00851440007834 ()


  • Wheelchair medical gas supply holder

SmartFrame - 00850359007072

SMARTFrame XG TwistPoint Kit w/ HC - E
Clearpoint Neuro, Inc.
CP-NGS-11-HC-TP32-E
Not in Commercial Distribution

  • 00850359007072 ()
CP-NGS-11-HC-TP32-E

  • Neurological stereotactic surgery system

Widex - 05706069839944

HA EJY E-PA E22 E 220 DEBLU
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839944 ()
10989662

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839937

HA EJY E-PA E22 E 220 ATBG
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839937 ()
10989661

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839920

HA EJY E-PA E22 E 220 TMGR
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839920 ()
10989660

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839913

HA EJY E-PA E22 E 220 SLVGR
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839913 ()
10989659

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839906

HA EJY E-PA E22 E 220 TCBLK
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839906 ()
10989658

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839890

HA EJY E-PA E22 E 220 TANS
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839890 ()
10989657

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839883

HA EJY E-PA E22 E 220 MTQS
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839883 ()
10989656

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839876

HA EJY E-PA E22 E 220 SHPK
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839876 ()
10989655

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839869

HA EJY E-PA E22 E 220 SRED
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839869 ()
10989654

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839852

HA EJY E-PA E22 E 220 LMGRN
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839852 ()
10989653

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839845

HA EJY E-PA E22 E 220 CABRN
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839845 ()
10989652

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839838

HA EJY E-PA E22 E 220 SGLD
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839838 ()
10989651

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839821

HA EJY E-PA E22 E 220 PRWHT
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839821 ()
10989650

  • Air-conduction hearing aid, receiver-in-canal

Morrison Medical - 00647921135062

9' POLY STRAP CUSTOM E Z LIFT
MORRISON MEDICAL, LTD
1350OREZ-9
In Commercial Distribution

  • 00647921135062 ()
1350OREZ-9

  • Limb/torso/head restraint, reusable

Morrison Medical - 00647921135055

7' POLY STRAP CUSTOM E Z LIFT
MORRISON MEDICAL, LTD
1350OREZ-7
In Commercial Distribution

  • 00647921135055 ()
1350OREZ-7

  • Limb/torso/head restraint, reusable

iTotal® Hip Replacement System - M572HDL060E34S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM LAT STD
Conformis, Inc.
HDL060E34S01
In Commercial Distribution

  • M572HDL060E34S011 ()

  • Group E 40mm LAT STD
HDL060E34S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E32S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM STD (PLN)
Conformis, Inc.
HDL060E32S01
In Commercial Distribution

  • M572HDL060E32S011 ()

  • Group E 40mm STD
HDL060E32S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30S011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 STD
Conformis, Inc.
HDL060E30S01
In Commercial Distribution

  • M572HDL060E30S011 ()

  • Group E 40mm +0 STD
HDL060E30S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30L011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 LIP
Conformis, Inc.
HDL060E30L01
In Commercial Distribution

  • M572HDL060E30L011 ()

  • Group E 40mm +0 LIP
HDL060E30L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E30F011

HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC
Conformis, Inc.
HDL060E30F01
In Commercial Distribution

  • M572HDL060E30F011 ()

  • Group E 40mm +0 FC
HDL060E30F

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E24S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM LAT STD
Conformis, Inc.
HDL060E24S01
In Commercial Distribution

  • M572HDL060E24S011 ()

  • Group E 36mm LAT STD
HDL060E24S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E22S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM STD (PLN)
Conformis, Inc.
HDL060E22S01
In Commercial Distribution

  • M572HDL060E22S011 ()

  • Group E 36mm STD
HDL060E22S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E20S011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +0 STD
Conformis, Inc.
HDL060E20S01
In Commercial Distribution

  • M572HDL060E20S011 ()

  • Group E 36mm +0 STD
HDL060E20S

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E20L011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +0 LIP
Conformis, Inc.
HDL060E20L01
In Commercial Distribution

  • M572HDL060E20L011 ()

  • Group E 36mm +0 LIP
HDL060E20L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E20F011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +0 FC
Conformis, Inc.
HDL060E20F01
In Commercial Distribution

  • M572HDL060E20F011 ()

  • Group E 36mm +0 FC
HDL060E20F

  • Non-constrained polyethylene acetabular liner

DJO SURGICAL - 00190446254546

DISC ULNA 5X155MM RT W/ E+ BRNG
Encore Medical, L.P.
540-65-155
In Commercial Distribution

  • 00190446254546 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254539

DISC ULNA 5X155MM LT W/ E+ BRNG
Encore Medical, L.P.
540-55-155
In Commercial Distribution

  • 00190446254539 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254522

DISC ULNA 5X115MM RT W/ E+ BRNG
Encore Medical, L.P.
540-65-115
In Commercial Distribution

  • 00190446254522 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254515

DISC ULNA 5X115MM LT W/ E+ BRNG
Encore Medical, L.P.
540-55-115
In Commercial Distribution

  • 00190446254515 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254508

DISC ULNA 5X75MM RT W/ E+ BRNG
Encore Medical, L.P.
540-65-075
In Commercial Distribution

  • 00190446254508 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254492

DISC ULNA 5X75MM LT W/ E+ BRNG
Encore Medical, L.P.
540-55-075
In Commercial Distribution

  • 00190446254492 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254485

DISC ULNA 4X155MM RT W/ E+ BRNG
Encore Medical, L.P.
540-64-155
In Commercial Distribution

  • 00190446254485 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254478

DISC ULNA 4X155MM LT W/ E+ BRNG
Encore Medical, L.P.
540-54-155
In Commercial Distribution

  • 00190446254478 ()


  • Metal-backed elbow ulna prosthesis

DJO SURGICAL - 00190446254461

DISC ULNA 4X115MM RT W/ E+ BRNG
Encore Medical, L.P.
540-64-115
In Commercial Distribution

  • 00190446254461 ()


  • Metal-backed elbow ulna prosthesis
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