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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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American Eagle Instruments - 00841013103605

CURETTE INDIANA U 13-14 (5/16)
AMERICAN EAGLE INSTRUMENTS, INC.
AECIU13-14L
In Commercial Distribution

  • 00841013103605 ()
AECIU13-14L

  • Periodontal curette

American Eagle Instruments - 00841013103124

CARVER U OF TEX REEVES & ROACH
AMERICAN EAGLE INSTRUMENTS, INC.
AECAUTRR
In Commercial Distribution

  • 00841013103124 ()
AECAUTRR

  • Dental restoration carver, amalgam, reusable

KLOCKNER - 08435451606624

CASTABLE FOR VEGA PERMANENT ABUTMENT [U]
SOADCO, S.L.
18 12 03
In Commercial Distribution

  • 08435451606624 ()
18 12 03

  • Dental implant suprastructure kit

KLOCKNER - 08435451602381

EC G 12° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 14 GU
In Commercial Distribution

  • 08435451602381 ()
10 12 14 GU

  • Dental implant suprastructure kit

KLOCKNER - 08435451602329

EC G 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 06 GU
In Commercial Distribution

  • 08435451602329 ()
10 12 06 GU

  • Dental implant suprastructure kit

KLOCKNER - 08435451602305

EC G 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 05 GU
In Commercial Distribution

  • 08435451602305 ()
10 12 05 GU

  • Dental implant suprastructure kit

MedSource Rebreather Mask - 00840155400047

Rebreather, Ped, Elongated w/ U. Conn
MEDSOURCE INTERNATIONAL LLC
MS-25056-U
In Commercial Distribution

  • 00840155400054 ()
  • 00840155400047 ()
Not Applicable

  • Rebreathing oxygen face mask

KLOCKNER - 08435451610850

SK2 25° ANGLED CASTABLE ABUTMENT [U]
SOADCO, S.L.
9030
In Commercial Distribution

  • 08435451610850 ()
9030

  • Dental implant suprastructure kit

ZOLL-DENTAL - 00840105211570

U of MN Modified Cut-Out (Economy)
Zoll-Dental
RET-UofMN-CUT
In Commercial Distribution

  • 00840105211570 ()


  • Hand-held dental retractor

ZOLL-DENTAL - 00840105214717

U of MN Retractor (in handle)
Zoll-Dental
RET-UofMN503
In Commercial Distribution

  • 00840105214717 ()


  • Hand-held dental retractor

Medline Industries, Inc. - 10884389897379

NEWBORN RESUSCIT KIT,U OF ALA
MEDLINE INDUSTRIES, INC.
DYK1060193NR
In Commercial Distribution

  • 10884389897379 ()
  • 40884389897370 ()
DYK1060193NR

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10884389626320

U H S HEART PACK SC
MEDLINE INDUSTRIES, INC.
DYNJ07951I
In Commercial Distribution

  • 10884389626320 ()
DYNJ07951I

  • General surgical procedure kit, non-medicated, reusable

Palmero Healthcare, LLC - 00840415105545

Protectall, Child, .25mm U, HT, Smiley
Palmero Healthcare LLC
27UHSMILEY
In Commercial Distribution

  • 00840415105545 ()
27UHSMILEY

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105538

Protectall, Child, .25mm U, HT, Black
Palmero Healthcare LLC
27UHBLACK
In Commercial Distribution

  • 00840415105538 ()
27UHBLACK

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105521

Protectall, Child, .25mm U, HT, Lavender
Palmero Healthcare LLC
27UHLAVENDER
In Commercial Distribution

  • 00840415105521 ()
27UHLAVENDER

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105514

Protectall, Child, .25mm U, HT, Royal
Palmero Healthcare LLC
27UHROYALBLUE
In Commercial Distribution

  • 00840415105514 ()
27UHROYALBLUE

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105507

Protectall, Child, .25mm U, HT, Grey
Palmero Healthcare LLC
27UHGREY
In Commercial Distribution

  • 00840415105507 ()
27UHGREY

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105491

Protectall, Child, .25mm U, HT, Blue
Palmero Healthcare LLC
27UHBLUE
In Commercial Distribution

  • 00840415105491 ()
27UHBLUE

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105484

Protectall, Child, .25mm U, HT, Beige
Palmero Healthcare LLC
27UHBEIGE
In Commercial Distribution

  • 00840415105484 ()
27UHBEIGE

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105477

Protectall, Adult, .25mm U, HT, Royal
Palmero Healthcare LLC
24UHROYALBLUE
In Commercial Distribution

  • 00840415105477 ()
24UHROYALBLUE

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105460

Protectall, Adult, .25mm U, HT, Lavender
Palmero Healthcare LLC
24UHLAVENDER
In Commercial Distribution

  • 00840415105460 ()
24UHLAVENDER

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105453

Protectall, Adult, .25mm U, HT, Grey
Palmero Healthcare LLC
24UHGREY
In Commercial Distribution

  • 00840415105453 ()
24UHGREY

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105446

Protectall, Adult, .25mm U, HT, Blue
Palmero Healthcare LLC
24UHBLUE
In Commercial Distribution

  • 00840415105446 ()
24UHBLUE

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105439

Protectall, Adult, .25mm U, HT, Black
Palmero Healthcare LLC
24UHBLACK
In Commercial Distribution

  • 00840415105439 ()
24UHBLACK

  • Radiation shielding apron

Palmero Healthcare, LLC - 00840415105422

Protectall, Adult, .25mm U, HT, Beige
Palmero Healthcare LLC
24UHBEIGE
In Commercial Distribution

  • 00840415105422 ()
24UHBEIGE

  • Radiation shielding apron

CARDINAL HEALTH - 10885425947751

STERILE T U R P PACK
Cardinal Health 200, LLC
SBA33TUCAC
In Commercial Distribution

  • 50885425947759 ()
  • 10885425947751 ()
SBA33TUCAC

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10885425847853

TOTAL HIP W U DRAPE SOUTHDALE
Cardinal Health 200, LLC
SOP15HUFSH
In Commercial Distribution

  • 50885425847851 ()
  • 10885425847853 ()
SOP15HUFSH

  • Orthopaedic surgical procedure kit, non-medicated, single-use

NA - 03596010250650

MTO HARNESS REPLACEMT PS3500EP C/U
Smith & Nephew, Inc.
7204890
Not in Commercial Distribution

  • 03596010250650 ()
7204890

  • Arthroscopic shaver system, electrically-powered

SpiritMB - 00889989007466

ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
495-1411
Not in Commercial Distribution

  • 00889989007466 ()
  • 10889989007463 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007459

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
495-1410
Not in Commercial Distribution

  • 00889989007459 ()
  • 10889989007456 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007398

ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
495-0411
Not in Commercial Distribution

  • 00889989007398 ()
  • 10889989007395 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007381

ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
495-0410
Not in Commercial Distribution

  • 00889989007381 ()
  • 10889989007388 ()

  • Slot: .022, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007213

ID U - Twin - Lower-Left Cuspid-Hook - Purple
ORMCO CORPORATION
494-1411
Not in Commercial Distribution

  • 00889989007213 ()
  • 10889989007210 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007206

ID U - Twin - Lower-Right Cuspid-Hook - Purple
ORMCO CORPORATION
494-1410
Not in Commercial Distribution

  • 00889989007206 ()
  • 10889989007203 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007084

ID U - Twin - Lower-Left Cuspid - Purple
ORMCO CORPORATION
494-0411
Not in Commercial Distribution

  • 00889989007084 ()
  • 10889989007081 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007077

ID U - Twin - Lower-Right Cuspid - Purple
ORMCO CORPORATION
494-0410
Not in Commercial Distribution

  • 00889989007077 ()
  • 10889989007074 ()

  • Slot: .018, Torque: -7


  • Orthodontic bracket, plastic, single-use

NORDENT MANUFACTURING INC - 00840018610798

SE SCALER U OF TEXAS 106
NORDENT MANUFACTURING INC
SCUT106
In Commercial Distribution

  • 00840018610798 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018610781

SE SCALERS U OF TEXAS 103
NORDENT MANUFACTURING INC
SCUT103
In Commercial Distribution

  • 00840018610781 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018608313

DE SCALER U of TEX 103-106
NORDENT MANUFACTURING INC
SC103-106
In Commercial Distribution

  • 00840018608313 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018606494

SE PROBE U OF MICH O
NORDENT MANUFACTURING INC
PUMO
In Commercial Distribution

  • 00840018606494 ()


  • Periodontal probe, reusable

BURKHART DENTAL - 00840018603011

BDS CHEEK RETRACTOR U OF MINN
NORDENT MANUFACTURING INC
CRM/BH
In Commercial Distribution

  • 00840018603011 ()


  • Hand-held dental retractor

ANAXDENT PMMA BLANK - 08435288418018

ANAXDENT PMMA BLANK U CLEAR 20mm
UNION DENTAL SA
PMMA Blank U CLEAR 20mm
Not in Commercial Distribution

  • 08435288418018 ()
18100020

  • Temporary dental crown/bridge

ANAXDENT PMMA BLANK - 08435288418001

ANAXDENT PMMA BLANK U CLEAR 16mm
UNION DENTAL SA
PMMA Blank U CLEAR 16mm
Not in Commercial Distribution

  • 08435288418001 ()
18100030

  • Temporary dental crown/bridge

MERIDIAN - 00815067043415

SG-5 U/C SAFE-T-GUARD 5'' AIR
COMPASS HEALTH BRANDS CORP.
SG5_FG
In Commercial Distribution

  • 00815067043415 ()


  • Limb/torso/head restraint, reusable

MERIDIAN - 00815067043408

SG-8 U/C SAFE-T-GUARD 8'' AIR
COMPASS HEALTH BRANDS CORP.
SG8_FG
In Commercial Distribution

  • 00815067043408 ()


  • Limb/torso/head restraint, reusable

PM 25 V3 U F KP - B800PM25V3UFKP0

PM 25 V3 U F KP
UTAK LABORATORIES, INC.
PM 25 V3 U F KP
In Commercial Distribution

  • B800PM25V3UFKP5 ()
  • B800PM25V3UFKP0 ()

  • Total Volume: 2 Milliliter
PM 25 V3 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control

Standard Edgewise - D78826274000531

LEW 022/U&L4&5 MED
Gc Orthodontics America Inc.
26-2740-0053
In Commercial Distribution

  • D78826274000531 ()
  • D78826274000530 ()
26-2740-0053

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000621

SW EDGE 022/U&L3 XWD
Gc Orthodontics America Inc.
26-2730-0062
In Commercial Distribution

  • D78826273000621 ()
  • D78826273000620 ()
26-2730-0062

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000591

SW EDGE 022/U&L3 WD
Gc Orthodontics America Inc.
26-2730-0059
In Commercial Distribution

  • D78826273000591 ()
  • D78826273000590 ()
26-2730-0059

  • Orthodontic bracket, metal

Experience - D788202E0300211

EXM MBT 022 U 3-3, SP3HK
Gc Orthodontics America Inc.
20-2E03-0021
In Commercial Distribution

  • D788202E0300211 ()
20-2E03-0021

  • Orthodontic bracket, metal
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