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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BioStep LP, Size 25, Right, Rate E
Alps South, LLC
BSLP-25RE
In Commercial Distribution

  • 00713980022473 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 25, Left, Rate E
Alps South, LLC
BSLP-25LE
In Commercial Distribution

  • 00713980022312 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 24, Left, Rate E
Alps South, LLC
BSLP-24LE
In Commercial Distribution

  • 00713980022152 ()


  • Mechanical-resistance external ankle-foot prosthesis
Motor Control, ProStyle E, reversing, with hose
LARES RESEARCH
Control, Motor, ProStyle E, Electric FO E-Type
Not in Commercial Distribution

  • D9501318601 ()
13186

  • Surgical power tool system control unit, line-powered
CUSTOM PACK CB7Y78R 3/8 E B
MEDTRONIC, INC.
CB7Y78R
In Commercial Distribution

  • 00643169366701 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB6Z18R3 1/4 E RP
MEDTRONIC, INC.
CB6Z18R3
In Commercial Distribution

  • 00643169098121 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7G20R3 3/8X1/4 E
MEDTRONIC, INC.
TL7G20R3
In Commercial Distribution

  • 00643169117921 ()


  • Cardiopulmonary bypass system blood tubing set
KIT LABOR & DELIVERY D&C/D&E
MEDLINE INDUSTRIES, INC.
DYKMBNDL31
In Commercial Distribution

  • 10193489478716 ()
  • 40193489478717 ()
DYKMBNDL31

  • General surgical procedure kit, non-medicated, single-use
CUSTOM PACK TL4B24R4 3/8 E P
MEDTRONIC, INC.
TL4B24R4
In Commercial Distribution

  • 00643169349087 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL3T02R6 1/4 E P
MEDTRONIC, INC.
TL3T02R6
In Commercial Distribution

  • 00643169349070 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB1L33R31 3/8 RD E
MEDTRONIC, INC.
CB1L33R31
Not in Commercial Distribution

  • 00643169341159 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5W39R23 1/4 RD E
MEDTRONIC, INC.
CB5W39R23
Not in Commercial Distribution

  • 00643169341142 ()


  • Cardiopulmonary bypass system blood tubing set
HISTOCORE SPECTRA H&E STAINING SYSTEM S3
Leica Biosystems Richmond, Inc.
3801658
In Commercial Distribution

  • 00849832021247 ()

  • Device Size Text, specify:
3801658

  • Biological stain IVD
HistoCore SPECTRA H&E Staining System S1-800
Leica Biosystems Richmond, Inc.
3801656
In Commercial Distribution

  • 00849832020523 ()

  • Device Size Text, specify:
3801656

  • Biological stain IVD
HistoCore SPECTRA H&E Staining System S1
Leica Biosystems Richmond, Inc.
000000000003801654
In Commercial Distribution

  • 00849832013464 ()

  • Device Size Text, specify:


  • Biological stain IVD
IPS Empress Esthetic Ingot E TC0/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574562
Not in Commercial Distribution

  • DIVO5745621 ()
  • DIVO5745620 ()
  • DIVO5745622 ()
574562

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E TC1/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574557
Not in Commercial Distribution

  • DIVO5745571 ()
  • DIVO5745570 ()
  • DIVO5745572 ()
574557

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E O1/5pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574555
Not in Commercial Distribution

  • DIVO5745551 ()
  • DIVO5745550 ()
  • DIVO5745552 ()
574555

  • Dental appliance fabrication material, ceramic
IPS Empress Esthetic Ingot E TC0/10pcs
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
574520
Not in Commercial Distribution

  • DIVO5745201 ()
  • DIVO5745200 ()
  • DIVO5745202 ()
574520

  • Dental appliance fabrication material, ceramic
CUSTOM PACK 5G81R5 3/8 E. PK
MEDTRONIC, INC.
5G81R5
Not in Commercial Distribution

  • 00643169181014 ()


  • Cardiopulmonary bypass system blood tubing set
Cylinder Roller Bag — Dual D/E Tank
SUNSET HEALTHCARE SOLUTIONS, INC.
CSBD2Roller
In Commercial Distribution

  • 00848530087777 ()


  • Home CPAP/BPAP washer/disinfector device container
LITHOTOMY PACK D C, D E PACK
Cardinal Health 200, LLC
SMA11NLNUH
In Commercial Distribution

  • 50888439979457 ()
  • 10888439979459 ()
SMA11NLNUH

  • Obstetrical/gynaecological surgical procedure kit, medicated
SAIPH Fixed Tibial Tray Cemented Size E
MATORTHO LTD
193-604
In Commercial Distribution

  • 05055455506190 ()
193-604

  • Uncoated knee tibia prosthesis, metallic
8-15 SHEER&SOFT PANTY CT NATURAL E
MEDI MANUFACTURING, INC.
02605
In Commercial Distribution

  • 00636257026052 ()


  • Compression/pressure sock/stocking, single-use
8-15 SHEER&SOFT PANTY CT EBONY E
MEDI MANUFACTURING, INC.
02655
In Commercial Distribution

  • 00636257026557 ()


  • Compression/pressure sock/stocking, single-use
SCALERS ANTERIOR N128 S/E SINGLE END
Power Dental U.S.A. Inc.
1303
In Commercial Distribution

  • D94313030 ()
1303

  • Dental excavator, reusable
  • Manual dental scaler, reusable
312/E/3.30 E-010/012 Curtain (Panels)
KENEX (ELECTRO-MEDICAL) LIMITED
312/E/3.30
In Commercial Distribution

  • 05055449407069 ()
312/E/3.30

  • Radiation shielding curtain
PERIOTOME POWER FLEX FPT-1 D/E DURABLE
Power Dental U.S.A. Inc.
1930-5
In Commercial Distribution

  • D943193050 ()
1930-5

  • Orthodontic pliers
  • Periotome, reusable
PERIOTOME POWER FLEX FPT-2 D/E DURABLE
Power Dental U.S.A. Inc.
1930-4
In Commercial Distribution

  • D943193040 ()
1930-4

  • Orthodontic pliers
  • Periotome, reusable
POWER FLEX PERIOTOME CVD S/E DURABLE
Power Dental U.S.A. Inc.
1930-2
In Commercial Distribution

  • D943193020 ()
1930-2

  • Orthodontic pliers
  • Periotome, reusable
POWER FLEX PERIOTOME STR S/E DURABLE
Power Dental U.S.A. Inc.
1930-1
In Commercial Distribution

  • D943193010 ()
1930-1

  • Orthodontic pliers
  • Periotome, reusable
Astrus Elite 3", Shampaine 4900B,E Foot
HILL-ROM, INC.
900113
In Commercial Distribution

  • 00615521016838 ()
H-303-04-103

  • Operating table mattress, basic
AR-T12E SINGLE PIECE E ADAPTER 1.2X OTV-
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS AR-T12E
In Commercial Distribution

  • 04953170023804 ()
5391830

  • Endoscope camera adaptor
SUSANO Pad for Seat Section Type E
MIZUHO CORPORATION
18-042-26
In Commercial Distribution

  • 04946329395365 ()

  • Length: 480 Millimeter
18-042-26

  • Operating table mattress, basic
ELEVATOR COTTLE SEPTUM D/E 9" 23CM
ACE SURGICAL SUPPLY CO., INC.
0300029
In Commercial Distribution

  • 00614950010745 ()

  • Length: 23 Centimeter
0300029

  • Dental elevator, tooth/root
RETRACTOR FELDMAN D/E 5-1/2" 14CM
ACE SURGICAL SUPPLY CO., INC.
0100394
In Commercial Distribution

  • 00614950017355 ()

  • Length: 5.5 Inch
0100394

  • Hand-held dental retractor
RETRACTOR HOUSE HAND D/E 6" 15CM
ACE SURGICAL SUPPLY CO., INC.
0100188
In Commercial Distribution

  • 00614950017270 ()

  • Length: 6 Inch
0100188

  • Hand-held dental retractor
CUSTOM PACK CB5V43R 1/4 E B
MEDTRONIC, INC.
CB5V43R
Not in Commercial Distribution

  • 00613994479389 ()


  • Cardiopulmonary bypass system blood tubing set
TRAY 7068304 TRAY E - 4.75 GEN INSTRMTS
MEDTRONIC SOFAMOR DANEK, INC.
7068304
In Commercial Distribution

  • 00613994617705 ()


  • Instrument tray, reusable
CUSTOM PACK CB5A32R9 E 1/4X3/8
MEDTRONIC, INC.
CB5A32R9
Not in Commercial Distribution

  • 00613994958518 ()


  • Cardiopulmonary bypass system blood tubing set
RES 24106 E NEONATE ANGUL CATH 7CM
MEDTRONIC PS MEDICAL, INC.
24106 E
In Commercial Distribution

  • 00613994908261 ()

  • Length: 7.0 Centimeter


  • Cranial port/reservoir
1608-2-15 MICRO BUR,RND BUR,16-FLT,E
MEDLINE INDUSTRIES, INC.
1608215RH
In Commercial Distribution

  • 10080196385041 ()
1608215RH

  • Orthopaedic bur, single-use
CUSTOM PACK 1E53R7 3/8X1/4 E
MEDTRONIC, INC.
1E53R7
Not in Commercial Distribution

  • 00613994951557 ()


  • Cardiopulmonary bypass system blood tubing set
e•Sense 7Fr Dual Sensor Urethral Catheter
Laborie Medical Technologies Corp.
CATEB37
In Commercial Distribution

  • 10627825013540 ()
  • 00627825013543 ()
  • 20627825013547 ()


  • Urodynamic manometric catheter, electronic, single-use
e•Sense 7Fr Single Sensor Bladder Catheter
Laborie Medical Technologies Corp.
CATEB27
In Commercial Distribution

  • 00627825013529 ()
  • 10627825013526 ()
  • 20627825013523 ()


  • Urodynamic manometric catheter, electronic, single-use
WMC D C AND D E PACK
Cardinal Health 200, LLC
SMA53DCKW1
In Commercial Distribution

  • 50888439217894 ()
  • 10888439217896 ()
SMA53DCKW1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
PBC228-E (Medium Clip Applier,28cm E Etched)
VITALITEC INTERNATIONAL, INC.
PBC228-E
In Commercial Distribution

  • 00857987006927 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
PB215-E (Medium Clip Applier, 15cm, E Etched)
VITALITEC INTERNATIONAL, INC.
PB215-E
In Commercial Distribution

  • 00857987006804 ()

  • Length: 15 Centimeter


  • Open-surgery ligation clip applier
PO428-E (Large Clip Applier, 28cm E Etched)
VITALITEC INTERNATIONAL, INC.
PO428-E
In Commercial Distribution

  • 00857987006644 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
Single D/E Oxygen Cylinder Wheelchair Bracket
RESPONSIVE RESPIRATORY, INC.
150-0110
In Commercial Distribution

  • 00851440007407 ()


  • Wheelchair medical gas supply holder
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