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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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Unimed - 06945664821162

Reusable SpO2 Sensor/超思/Finger clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410B-96
In Commercial Distribution

  • 06945664821162 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664821155

Reusable SpO2 Sensor/超思/Soft Tip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410S-96
In Commercial Distribution

  • 06945664821155 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664824439

Reusable SpO2 Sensor/Nellcor-OXIMAX/Soft finger cover/Pediatric/1.1M/103X/Pacific公司
Unimed Medical Supplies, Inc.
NSNE1726
In Commercial Distribution

  • 06945664824439 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664883177

ECG Monitor Trunk Cable/Datascope/DT style/5-lead/AHA&IEC/2.5M/345/TENACORE公司
Unimed Medical Supplies, Inc.
TC-DT-2526
In Commercial Distribution

  • 06945664883177 ()


  • Electrical-only medical device connection cable, reusable

212NY - 00860013168926

LEVEL 2 DISPOSABLE ISOLATION GOWN - 10 PACK
Two One Two New York, Inc.
27000XL
In Commercial Distribution

  • 10860013168923 ()
  • 00860013168926 ()
  • 00860013168933 ()
27000XL

  • Isolation gown, single-use

212NY - 00860013168902

LEVEL 2 DISPOSABLE ISOLATION GOWN-10 PACK
Two One Two New York, Inc.
27000L
In Commercial Distribution

  • 00860013168919 ()
  • 00860013168902 ()
  • 10860013168909 ()
27000L

  • Isolation gown, single-use

212NY - G33527000XL1

IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI - SIZE XLARGE 10 PACK
Two One Two New York, Inc.
27000
In Commercial Distribution

  • G33527000XL1 ()
  • G33527000XL2 ()
  • G33527000XL0 ()
27000

  • Isolation gown, single-use

212NY - G33527000L1

IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI - SIZE LARGE 10 PACK
Two One Two New York, Inc.
27000
In Commercial Distribution

  • G33527000L1 ()
  • G33527000L2 ()
  • G33527000L0 ()
27000

  • Isolation gown, single-use

Synergetics - 10841305111438

25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)

Synergetics - 10841305111414

23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)

Salvin Dental Specialties - 00841336111530

Salvin TG Driver
SALVIN DENTAL SPECIALTIES, LLC
TG
In Commercial Distribution

  • 00841336111530 ()
TG

  • Dental torque wrench

TG - 00844868010098

TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable

ZOLL-DENTAL - 00840105209829

TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe

125-280 Solution™ for STERIZONE VP4 Sterilizer - 00690455440102

The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
TSO3 Inc
44010
In Commercial Distribution

  • 00690455045604 ()
  • 00690455440102 ()
44010

  • Hydrogen peroxide device sterilant

STERIZONE® VP4 Sterilizer - 00690455440003

The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
TSO3 Inc
44000-R
In Commercial Distribution

  • 00690455440003 ()
44000-R

  • Ozone/hydrogen peroxide sterilizer

KONMED /Pelvifine - 06970935830543

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device

KONMED /Pelvifine - 06970935830536

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device

Miracle Ear App - 00860001471731

Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control

Miracle Ear App - 00860001471724

Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control

Miracle-Ear App - 00860001471717

App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control

Miracle-Ear App - 00860001471700

App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control

Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

HU-FRIEDY - 10889950007393

TG Chisel, Modified
HU-FRIEDY MFG. CO., LLC
CTG-O6
In Commercial Distribution

  • 10889950007393 ()
CTG-O6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007386

Modified TG Chisel
HU-FRIEDY MFG. CO., LLC
CTG-O
In Commercial Distribution

  • 10889950007386 ()
CTG-O

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007379

TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG6
In Commercial Distribution

  • 10889950007379 ()
CTG6

  • Periodontal file/rasp, manual

HU-FRIEDY - 10889950007362

TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG
In Commercial Distribution

  • 10889950007362 ()
CTG

  • Periodontal file/rasp, manual

Power Dental USA - D94320060

KRAMER NEVINES TG
Power Dental U.S.A. Inc.
2006
In Commercial Distribution

  • D94320060 ()
2006

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

KOHDENT - 04251436926839

PA-Chisel - TRINOVO - TG
Kohler Medizintechnik GmbH
7645
In Commercial Distribution

  • 04251436926839 ()
7645

  • Orthopaedic chisel

ZOLL-DENTAL - 00840105209744

Kirkland #13K/TG
Zoll-Dental
PC-Kirk13K/TG
In Commercial Distribution

  • 00840105209744 ()


  • Periodontal hoe

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

Berichrom Antithrombin III (A) - 00630414639659

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873899
In Commercial Distribution

  • 00630414639659 ()
10873899

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom Antithrombin III (A) - 00630414639444

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873898
In Commercial Distribution

  • 00630414639444 ()
10873898

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom® Antithrombin III (A) - 00842768013478

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446673
In Commercial Distribution

  • 00842768013478 ()
OWWR17

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom® Antithrombin III (A) - 00842768013461

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446672
In Commercial Distribution

  • 00842768013461 ()
OWWR15

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Power Dental USA - D94317070

SCALER/HOE U15/TG
Power Dental U.S.A. Inc.
1707
In Commercial Distribution

  • D94317070 ()
1707

  • Dental excavator, reusable
  • Manual dental scaler, reusable

n.a. - 04048551102282

Obturator for 26182 TG
Karl Storz GmbH & Co. KG
26182TH
In Commercial Distribution

  • 04048551102282 ()


  • Rigid endoscope obturator

Salvin Dental Specialties - 00841336106437

Salvin TG Periodontal Chisel
SALVIN DENTAL SPECIALTIES, LLC
PERIO-CHISEL-TG
In Commercial Distribution

  • 00841336106437 ()
PERIO-CHISEL-TG

  • Dental osteotome

TITAN IMPLANTS, INC. - 00842448116390

TG Post Abutment Driver
TITAN IMPLANT INC
T-TGAD
In Commercial Distribution

  • 00842448116390 ()


  • Surgical screwdriver, reusable

NORDENT MANUFACTURING INC - 00840018641600

PERIODONTAL CHISEL, DE, TG
NORDENT MANUFACTURING INC
CECPTG
In Commercial Distribution

  • 00840018641600 ()


  • Periodontal hoe

ITL Dental - 00817686024189

TGDN TG POST DRIVER
EMERY ENTERPRISES INC
TGDN
In Commercial Distribution

  • 00817686024189 ()


  • Screw endosteal dental implant, two-piece

Medline Industries, Inc. - 10198459185106

PK, TG HEART ACCESSORY
MEDLINE INDUSTRIES, INC.
DYNJ88616
In Commercial Distribution

  • 40198459185107 ()
  • 10198459185106 ()
DYNJ88616

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

CERAMAGE - E23523640

CERAMAGE UP TG 5G
SHOFU DENTAL CORPORATION
2364
In Commercial Distribution

  • E23523640 ()
2364

  • Dental prosthesis veneer resin

Ceramage - E23519340

Ceramage Trans Effects TG
SHOFU DENTAL CORPORATION
1934
In Commercial Distribution

  • E23519340 ()
1934

  • Dental prosthesis veneer resin

STOMA® - ESAM12843001

Chisel, Kirkland 13K/TG
Storz am Mark GmbH
12843.00
In Commercial Distribution

  • ESAM12843000 ()
  • ESAM12843001 ()
12843.00

  • Periodontal knife

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system

HU-FRIEDY - 10889950022549

#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual

WISONIC - 06971355420642

No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system

Unimed - 06945664817004

SpO2 interface cable/Datex-Ohmeda/3.0M/064+128/GE OxyTip+/Diagramm Halbach公
Unimed Medical Supplies, Inc.
829132
In Commercial Distribution

  • 06945664817004 ()


  • Electrical-only medical device connection cable, reusable

Rexton - 05714880113204

APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control

AudioService - 05714880113198

APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
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