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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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iTotal® Hip Replacement System - M572HDL060E22L011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM LIP
Conformis, Inc.
HDL060E22L01
In Commercial Distribution

  • M572HDL060E22L011 ()

  • Group E 36mm LIP
HDL060E22L

  • Non-constrained polyethylene acetabular liner

iTotal® Hip Replacement System - M572HDL060E22F011

HIP-IPOLY XE-LINER-GRP E (58-63) 36MM FC
Conformis, Inc.
HDL060E22F01
In Commercial Distribution

  • M572HDL060E22F011 ()

  • Group E 36mm FC
HDL060E22F

  • Non-constrained polyethylene acetabular liner

DJO SURGICAL - 00190446254560

DISC ULNA X-SMALL E+ BEARING KIT
Encore Medical, L.P.
540-01-005
In Commercial Distribution

  • 00190446254560 ()


  • Metal-backed elbow ulna prosthesis

Locking Pin E - EBRE440006580

Locking Pin E completely 1 Piece
bredent GmbH & Co. KG
44000658
In Commercial Distribution

  • EBRE440006589 ()
  • EBRE440006580 ()
44000658

  • Bar dental precision attachment

Anmuth Medical International - 08403207004376

Probe D/E 2mm 25cm/10"
Anmuth Medical International, LLC
26-106-25
In Commercial Distribution

  • 08403207004376 ()

  • Length: 10 Inch
26-106-25

  • Neurosurgical probe

Anmuth Medical International - 08403207002402

CRILE Retractor D/E 11.5cm/4.5"
Anmuth Medical International, LLC
24-127-11
In Commercial Distribution

  • 08403207002402 ()

  • Length: 4.5 Inch
24-127-11

  • Hand-held surgical retractor, reusable

SCHWERT - E896363210

Root canal plugger d/e GLICK
A. Schweickhardt GmbH & Co. KG
3632-1
In Commercial Distribution

  • E896363210 ()
3632-1

  • Endodontic plugger

Autoclavable version of OW E UCT - 03701354401617

Autoclavable version of OW E UCT
PLASMABIOTICS
OW E UCT/A
In Commercial Distribution

  • 03701354401617 ()

  • Length: 34 Centimeter
  • Width: 23 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system

Hayden Medical - 00840319700235

Comedone extract, 4" D/E FLAT
Hayden Medical, Inc.
033-203
In Commercial Distribution

  • 00840319700235 ()
033-203

  • Comedo expressor

CT/MR OncoSmart Catheter System - 08717213022973

CT/MR Proximal Button E White
Nucletron B.V.
189817-00
In Commercial Distribution

  • 08717213022973 ()


  • General-purpose brachytherapy system applicator, remote-afterloading

Maquet Orchide - 03700712418281

OHDII FHD QL AIR04 E/U
MAQUET SAS
ARD568803968
Not in Commercial Distribution

  • 03700712418281 ()


  • Surgical video camera

NORDENT MANUFACTURING INC - 00840018628656

BURNISHER, DE, JUMBO BALL#25 E
NORDENT MANUFACTURING INC
REBR25-29
In Commercial Distribution

  • 00840018628656 ()


  • Manual dental burnisher, reusable

NORDENT MANUFACTURING INC - 00840018645462

PERIODON. FIL E ORBAN 10-11, D
NORDENT MANUFACTURING INC
REFPO10-11
In Commercial Distribution

  • 00840018645462 ()


  • Periodontal file/rasp, manual

NORDENT MANUFACTURING INC - 00840018645257

PERIODON. FIL E ORBAN 10-11, D
NORDENT MANUFACTURING INC
CEFPO10-11
In Commercial Distribution

  • 00840018645257 ()


  • Periodontal file/rasp, manual

PFT Kit E, VBMax30E - 00817081022292

Pulmonary Function Testing Kit E, VBMax30E
A-M SYSTEMS, LLC
PFT Kit E, VBMax30E - 189130
In Commercial Distribution

  • 00817081022308 ()
  • 00817081022292 ()
189130

  • Pulmonary function testing kit

PFT Kit E, VBMax28E - 00817081021950

Pulmonary Function Testing Kit E, VBMax28E
A-M SYSTEMS, LLC
PFT Kit E, VBMax28E - 189128
In Commercial Distribution

  • 00817081021967 ()
  • 00817081021950 ()
189128

  • Pulmonary function testing kit

Sklar® - 10649111101335

UNIVERSAL D/E SCALER #15/33
SKLAR CORPORATION
41-640
In Commercial Distribution

  • 10649111101335 ()


  • Manual dental scaler, reusable

Sklar® - 10649111086281

ROUX D/E RETRACTOR MEDIUM 6"
SKLAR CORPORATION
60-1102
In Commercial Distribution

  • 10649111086281 ()


  • Hand-held surgical retractor, reusable

Sklar - 10649111226410

COTTLE ELEV CM-GRAD D/E 9
SKLAR CORPORATION
41-1235
In Commercial Distribution

  • 10649111226410 ()


  • Bone lever/elevator, reusable

Sklar® - 10649111112850

TOWNER SCALER D/E U-15/30
SKLAR CORPORATION
41-709
In Commercial Distribution

  • 10649111112850 ()


  • Manual dental scaler, reusable
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