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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EMPERION 11 SLEEVE SMALL CONE 2 SPOUT
Smith & Nephew, Inc.
71291652
Not in Commercial Distribution

  • 03596010561572 ()
71291652

  • Coated hip femur prosthesis, modular
EMPERION 11 SLEEVE SMALL CONE 1 SPOUT
Smith & Nephew, Inc.
71291651
Not in Commercial Distribution

  • 03596010561565 ()
71291651

  • Coated hip femur prosthesis, modular
EMPERION STEM 11 SH REV POL + 10
Smith & Nephew, Inc.
71291151
Not in Commercial Distribution

  • 03596010561411 ()
71291151

  • Press-fit femoral stem prosthesis
EMPERION STEM 11 SH REV POL + 0
Smith & Nephew, Inc.
71291150
In Commercial Distribution

  • 03596010561404 ()
71291150

  • Press-fit femoral stem prosthesis
EMPERION 11 LG CONE 3 SPOUT TRIAL
Smith & Nephew, Inc.
71361232
Not in Commercial Distribution

  • 03596010569073 ()
71361232

  • Femoral stem prosthesis trial
EMPERION 11 LG CONE 2 SPOUT TRIAL
Smith & Nephew, Inc.
71361231
Not in Commercial Distribution

  • 03596010569066 ()
71361231

  • Femoral stem prosthesis trial
EMPERION 11 LG CONE 1 SPOUT TRIAL
Smith & Nephew, Inc.
71361230
Not in Commercial Distribution

  • 03596010569059 ()
71361230

  • Femoral stem prosthesis trial
EMPERION 11 MED CONE 3 SPOUT TRIAL
Smith & Nephew, Inc.
71361229
Not in Commercial Distribution

  • 03596010569042 ()
71361229

  • Femoral stem prosthesis trial
EMPERION 11 MED CONE 2 SPOUT TRIAL
Smith & Nephew, Inc.
71361228
Not in Commercial Distribution

  • 03596010569035 ()
71361228

  • Femoral stem prosthesis trial
EMPERION 11 MED CONE 1 SPOUT TRIAL
Smith & Nephew, Inc.
71361227
Not in Commercial Distribution

  • 03596010569028 ()
71361227

  • Femoral stem prosthesis trial
EMPERION 11 SM CONE 3 SPOUT TRIAL
Smith & Nephew, Inc.
71361226
Not in Commercial Distribution

  • 03596010569011 ()
71361226

  • Femoral stem prosthesis trial
EMPERION 11 SM CONE 2 SPOUT TRIAL
Smith & Nephew, Inc.
71361225
Not in Commercial Distribution

  • 03596010569004 ()
71361225

  • Femoral stem prosthesis trial
EMPERION 11 SM CONE 1 SPOUT TRIAL
Smith & Nephew, Inc.
71361224
Not in Commercial Distribution

  • 03596010568991 ()
71361224

  • Femoral stem prosthesis trial
EMPERION 11 SLEEVE LARGE CONE 3 SPOUT
Smith & Nephew, Inc.
71291659
Not in Commercial Distribution

  • 03596010561657 ()
71291659

  • Coated hip femur prosthesis, modular
LEGION TRIAL STEM 11 X 220 STRAIGHT
Smith & Nephew, Inc.
71434064
In Commercial Distribution

  • 03596010547798 ()
71434064

  • Knee femur prosthesis trial, reusable
EMPERION 11 HIGH OFFSET/REVISION TRIAL NECK
Smith & Nephew, Inc.
71364256
Not in Commercial Distribution

  • 03596010570130 ()
71364256

  • Femoral stem prosthesis trial
11 MM X 35 MM BIOSURE HA
Smith & Nephew, Inc.
72201790
In Commercial Distribution

  • 03596010611864 ()
72201790

  • Bioabsorbable orthopaedic bone screw
11 MM X 30 MM BIOSURE HA
Smith & Nephew, Inc.
72201789
In Commercial Distribution

  • 03596010611857 ()
72201789

  • Bioabsorbable orthopaedic bone screw
11 MM X 25 MM BIOSURE HA
Smith & Nephew, Inc.
72201788
In Commercial Distribution

  • 03596010611840 ()
72201788

  • Bioabsorbable orthopaedic bone screw
DJO EMPOWR KNEETM Tibial Template, 11 Right
Encore Medical, L.P.
801-05-369
In Commercial Distribution

  • 00190446239116 ()


  • Surgical implant template, reusable
DJO EMPOWR KNEETM Tibial Template, 11 Left
Encore Medical, L.P.
801-05-368
In Commercial Distribution

  • 00190446239109 ()


  • Surgical implant template, reusable
TRIGEN 11/9.5MM X 30CM HUMERAL NAIL
Smith & Nephew, Inc.
71771130
Not in Commercial Distribution

  • 03596010514653 ()
71771130

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 28CM HUMERAL NAIL
Smith & Nephew, Inc.
71771128
Not in Commercial Distribution

  • 03596010514646 ()
71771128

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 26CM HUMERAL NAIL
Smith & Nephew, Inc.
71771126
Not in Commercial Distribution

  • 03596010514639 ()
71771126

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 24CM HUMERAL NAIL
Smith & Nephew, Inc.
71771124
Not in Commercial Distribution

  • 03596010514622 ()
71771124

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 22CM HUMERAL NAIL
Smith & Nephew, Inc.
71771122
Not in Commercial Distribution

  • 03596010514615 ()
71771122

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 20CM HUMERAL NAIL
Smith & Nephew, Inc.
71771120
Not in Commercial Distribution

  • 03596010514608 ()
71771120

  • Humerus intramedullary nail
TRIGEN 11/9.5MM X 18CM HUMERAL NAIL
Smith & Nephew, Inc.
71771118
Not in Commercial Distribution

  • 03596010514592 ()
71771118

  • Humerus intramedullary nail
4.5MM BROAD COMPRESSION PLATE 11 HOLE 213MM
Smith & Nephew, Inc.
71809491
In Commercial Distribution

  • 03596010529367 ()
71809491

  • Orthopaedic fixation plate, non-bioabsorbable
4.5MM BROAD COMPRESSION PLATE 11 HOLE 213MM
Smith & Nephew, Inc.
71829491
In Commercial Distribution

  • 03596010527806 ()
71829491

  • Orthopaedic fixation plate, non-bioabsorbable
4.5MM NARROW COMPRESSION PLATE 11 HOLE 214MM
Smith & Nephew, Inc.
71829461
In Commercial Distribution

  • 03596010527738 ()
71829461

  • Orthopaedic fixation plate, non-bioabsorbable
4.5MM NARROW COMPRESSION PLATE 11 HOLE 214MM
Smith & Nephew, Inc.
71809461
In Commercial Distribution

  • 03596010523686 ()
71809461

  • Orthopaedic fixation plate, non-bioabsorbable
3.5MM SMALL COMPRESSION PLATE 11 HOLE 158MM
Smith & Nephew, Inc.
71809411
In Commercial Distribution

  • 03596010523457 ()
71809411

  • Orthopaedic fixation plate, non-bioabsorbable
Dawson-Yuhl-Leksell rongeur, 11'', double-action, straight, 4.0mm jaws
AMBLER SURGICAL CORP.
Dawson-Yuhl-Leksell rongeur
In Commercial Distribution

  • 00190660145934 ()
75-290

  • Orthopaedic joint/limb rongeur
HIPRX STEM SIZE 11 RIGHT OR LEFT
Conformis, Inc.
HES-034-0011-01
In Commercial Distribution

  • M572HES0340011011 ()

  • patient specific neck
HES-034-0011

  • Coated femoral stem prosthesis, one-piece
Shea ear speculum holder, 11 3/4''
AMBLER SURGICAL CORP.
Shea ear speculum holder
In Commercial Distribution

  • 00190660180577 ()
86-605

  • Self-retaining ear speculum
YEOMAN Rectal Biopsy Forceps, oval basket, 11"
BR Surgical, LLC
BR68-30128
In Commercial Distribution

  • 00840183525224 ()
BR68-30128

  • Open-surgery biopsy forceps, reusable
DEAVER Retractor, 25mm blade, 11 3/4"
BR Surgical, LLC
BR18-18325
In Commercial Distribution

  • 00840183523572 ()
BR18-18325

  • Hand-held surgical retractor, reusable
BAND MR MAND 2ND BICUSPID SZ 11
AMERICAN ORTHODONTICS CORPORATION
570-0U-1100
In Commercial Distribution

  • 00190746140648 ()
570-0U-1100

  • Orthodontic metal band
BAND MR MAND 1ST BICUSPID SZ 11
AMERICAN ORTHODONTICS CORPORATION
470-0U-1100
In Commercial Distribution

  • 00190746139987 ()
470-0U-1100

  • Orthodontic metal band
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