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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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LEONE SPA - 08033707038153

DB BRACKETS 18 CEN U
LEONE SPA
F2081-921
In Commercial Distribution

  • 08033707038153 ()
F2081-921

  • Orthodontic bracket, metal

LEONE SPA - 08033707038122

DB BRACKETS 18 CEN U
LEONE SPA
F2081-21
In Commercial Distribution

  • 08033707038122 ()
F2081-21

  • Orthodontic bracket, metal

Standard Edgewise - D78826173000121

SEW 018/U & L3 NARROW
Gc Orthodontics America Inc.
26-1730-0012
In Commercial Distribution

  • D78826173000120 ()
  • D78826173000121 ()
26-1730-0012

  • Orthodontic bracket, metal

EXPERIENCE® - D788202F0000201

EXM MBT 022 U 2-2
Gc Orthodontics America Inc.
20-2F00-0020
In Commercial Distribution

  • D788202F0000201 ()
20-2F00-0020

  • Orthodontic bracket, metal

EXPERIENCE® - D788171C0000101

EXL SB 018 U 5-5
Gc Orthodontics America Inc.
17-1C00-0010
In Commercial Distribution

  • D788171C0000100 ()
  • D788171C0000101 ()
17-1C00-0010

  • Orthodontic bracket, metal

Pitts21 - 00840273900832

P21 5X5 U HKS 345
World Class Technology Corporation
946.2160
In Commercial Distribution

  • 00840273900832 ()
946.2160

  • Orthodontic bracket, metal

Pitts21 - 00840273900818

P21 7X7 U HKS 345
World Class Technology Corporation
946.2152
In Commercial Distribution

  • 00840273900818 ()
946.2152

  • Orthodontic bracket, metal

Maquet ORCHIDE - 03700712415976

OHDII FHD QL AIR03 U
MAQUET SAS
ARD568803952
In Commercial Distribution

  • 03700712415976 ()


  • Surgical video camera

BETA - E53573B0U000161

BETA-Titan Form B 016 U
Gc Orthodontics America Inc.
73-B0U0-0016
In Commercial Distribution

  • E53573B0U000160 ()
  • E53573B0U000161 ()
73-B0U0-0016

  • Orthodontic archwire

BETA - E53573A0U018181

BETA-TITAN FORM A 18X18 U
Gc Orthodontics America Inc.
73-A0U0-1818
In Commercial Distribution

  • E53573A0U018180 ()
  • E53573A0U018181 ()
73-A0U0-1818

  • Orthodontic archwire

BIO-ACTIVE - E53570B0U016161

BIO-ACTIVE FORM B 16X16 U
Gc Orthodontics America Inc.
70-B0U0-1616
In Commercial Distribution

  • E53570B0U016160 ()
  • E53570B0U016161 ()
70-B0U0-1616

  • Orthodontic archwire

Corning - H10899941

CellSTACK Chamber,40-STACK,W/U
Corning Incorporated
9994
In Commercial Distribution

  • H10899943 ()
  • H10899941 ()
9994

  • Blood/tissue storage/culture container

Corning - H10899881

CellSTACK Chamber,10-STACK,W/U
Corning Incorporated
9988
In Commercial Distribution

  • H10899883 ()
  • H10899881 ()
9988

  • Blood/tissue storage/culture container

Walcott Rx Products - 00840516134949

U Shaped Hydrodissection Cannula 27g
Psi/Eye-Ko, Inc.
Rx7009U
In Commercial Distribution

  • 00840516133386 ()
  • 00840516134949 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Ultraview - 10841522108464

MDTM REC, UHF U, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522108464 ()
R-90478-U

  • Electrocardiography monitoring system receiver

N/A - D80705542221

LWS 022/U&L4-5 MED
DENTSPLY SIRONA ORTHODONTICS INC.
05-542-22
Not in Commercial Distribution

  • D80705542221 ()
  • D80705542220 ()
05-542-22

  • Orthodontic bracket, metal

AFFINITY MATTRESS U SET REPLACEMENT - 00840828162791

AFFINITY MATTRESS U SET REPLACEMENT
CURBELL MEDICAL PRODUCTS, INC.
SM-AFFINITY-USET
Not in Commercial Distribution

  • 00840828162791 ()
14612

  • Stretcher mattress

Straight Edge Metal Bracket Patient Kit - 00192029021323

U/L 5-5 0.56mm (0.022")
TP ORTHODONTICS INC
290-600
In Commercial Distribution

  • 00192029021323 ()


  • Orthodontic bracket, metal

CARDINAL HEALTH - 10887488148946

STERILE GENERAL U BAR PACK
Cardinal Health 200, LLC
SBA53UBMIG
In Commercial Distribution

  • 50887488148944 ()
  • 10887488148946 ()
SBA53UBMIG

  • General surgical procedure kit, medicated

N/A - D80737142321

SEW 022/U&L4-5 WD
DENTSPLY SIRONA ORTHODONTICS INC.
37-142-32
Not in Commercial Distribution

  • D80737142321 ()
  • D80737142320 ()
37-142-32

  • Orthodontic bracket, metal
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