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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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TiBase - E27668326090

TiBase AT EV 4.8 GH2 L
SIRONA Dental Systems GmbH
6832609
In Commercial Distribution

  • E27668326090 ()
6832609

  • Dental implant suprastructure, permanent, preformed

TiBase - E27668325830

TiBase AT EV 3.6 GH2 S
SIRONA Dental Systems GmbH
6832583
In Commercial Distribution

  • E27668325830 ()
6832583

  • Dental implant suprastructure, permanent, preformed

TiBase - E27668325750

TiBase AT EV 3.0 GH2 S
SIRONA Dental Systems GmbH
6832575
In Commercial Distribution

  • E27668325750 ()
6832575

  • Dental implant suprastructure, permanent, preformed

TiBase - E27665863462

TiBase AT EV 5.4 GH1 L
SIRONA Dental Systems GmbH
6586346
In Commercial Distribution

  • E27665863462 ()
6586346

  • Dental implant suprastructure, permanent, preformed

TiBase - E27665863382

TiBase AT EV 4.8 GH1 L
SIRONA Dental Systems GmbH
6586338
In Commercial Distribution

  • E27665863382 ()
6586338

  • Dental implant suprastructure, permanent, preformed

TiBase - E27665863202

TiBase AT EV 4.2 GH1 L
SIRONA Dental Systems GmbH
6586320
In Commercial Distribution

  • E27665863202 ()
6586320

  • Dental implant suprastructure, permanent, preformed

TiBase - E27665863122

TiBase AT EV 3.6 GH1 S
SIRONA Dental Systems GmbH
6586312
In Commercial Distribution

  • E27665863122 ()
6586312

  • Dental implant suprastructure, permanent, preformed

ScanPost - E27664310630

ScanPost AT OS 4.5/5.0 L
SIRONA Dental Systems GmbH
6431063
In Commercial Distribution

  • E27664310630 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

ScanPost - E27664310550

ScanPost AT OS 3.5/4.0 L
SIRONA Dental Systems GmbH
6431055
In Commercial Distribution

  • E27664310550 ()


  • Dental implant abutment analog, intraoral-scanning, single-use

General Instrument - 00840180507193

Angled Chisel - 15 degrees at 70mm
ALPHATEC SPINE, INC.
CI-10906
In Commercial Distribution

  • 00840180507193 ()


  • Orthopaedic chisel

TiBase - E27664604432

Abutment Screw AT OS 4.5/5.0
SIRONA Dental Systems GmbH
64 60 443
In Commercial Distribution

  • E27664604432 ()
  • E27662819140 ()
64 60 443

  • Dental implant suprastructure, permanent, preformed

TiBase - E27664603442

Abutment Screw AT OS 3.5/4.0
SIRONA Dental Systems GmbH
64 60 344
In Commercial Distribution

  • E27664603442 ()
  • E27662819060 ()
64 60 344

  • Dental implant suprastructure, permanent, preformed

CEREC Guide - E27663739502

Cerec Guide Drill Key Set AT
SIRONA Dental Systems GmbH
6373950
In Commercial Distribution

  • E27663739502 ()


  • CAD/CAM software

TiBase - E27662825400

TiBase AT OS 4.5/5.0 L
SIRONA Dental Systems GmbH
62 82 540
In Commercial Distribution

  • E27662825400 ()
62 82 540

  • Dental implant suprastructure, permanent, preformed

TiBase - E27662825320

TiBase AT OS 3.5/4.0 L
SIRONA Dental Systems GmbH
62 82 532
In Commercial Distribution

  • E27662825320 ()
62 82 532

  • Dental implant suprastructure, permanent, preformed

ACUMED - 10806378054716

AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device

CARDINAL HEALTH - 10195594188085

SC AT PELHAM TOTAL HIP PACK
Cardinal Health 200, LLC
SOP23THPLA
In Commercial Distribution

  • 50195594188083 ()
  • 10195594188085 ()
SOP23THPLA

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

CARDINAL HEALTH - 10195594188030

SC AT PELHAM LAP CHOLE PACK
Cardinal Health 200, LLC
SBA23LCPLA
In Commercial Distribution

  • 50195594188038 ()
  • 10195594188030 ()
SBA23LCPLA

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

CARDINAL HEALTH - 10195594188016

SC AT PELHAM KNEE ARTHRO PACK
Cardinal Health 200, LLC
SOP23KAPLA
In Commercial Distribution

  • 50195594188014 ()
  • 10195594188016 ()
SOP23KAPLA

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

CARDINAL HEALTH - 10195594374600

SC AT PELHAM KNEE ARTHRO PACK
Cardinal Health 200, LLC
SOP23KAPLB
In Commercial Distribution

  • 50195594374608 ()
  • 10195594374600 ()
SOP23KAPLB

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

CARDINAL HEALTH - 10195594374587

SC AT PELHAM TOTAL HIP PACK
Cardinal Health 200, LLC
SOP23THPLB
In Commercial Distribution

  • 50195594374585 ()
  • 10195594374587 ()
SOP23THPLB

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

CARDINAL HEALTH - 10195594827892

SC AT PELHAM KNEE ARTHRO PACK
Cardinal Health 200, LLC
SOP23KAPL1
In Commercial Distribution

  • 50195594827890 ()
  • 10195594827892 ()
SOP23KAPL1

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

Brasseler USA - 00887919676386

AT STILL DENT ACRYLIC ADJ/POL
Peter Brasseler Holdings, LLC
5022807U0
In Commercial Distribution

  • 00887919676386 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919676362

AT STILL LAB BUR BLOCK 1P
Peter Brasseler Holdings, LLC
5022805U0
In Commercial Distribution

  • 00887919676362 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919676331

AT STILL GOLD FINISH KIT 1P
Peter Brasseler Holdings, LLC
5022802U0
In Commercial Distribution

  • 00887919676331 ()


  • Diamond dental bur, single-use

CARDINAL HEALTH - 10197106005934

SC AT PELHAM TOTAL HIP PACK
Cardinal Health 200, LLC
SOP23THPLC
In Commercial Distribution

  • 50197106005932 ()
  • 10197106005934 ()
SOP23THPLC

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

CARDINAL HEALTH - 10197106003947

SC AT PELHAM LAP CHOLE PACK
Cardinal Health 200, LLC
SBA23LCPLC
In Commercial Distribution

  • 50197106003945 ()
  • 10197106003947 ()
SBA23LCPLC

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

Lac-Mac - 00627755057150

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 3XL
Lac-Mac Limited
005XH-3XL
In Commercial Distribution

  • 00627755057150 ()

  • Height: 54.5 Inch
  • Width: 33.5 Inch
005XH-3XL

  • Surgical gown, reusable

Lac-Mac - 00627755056979

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 2XL
Lac-Mac Limited
005XFAN-2XL
In Commercial Distribution

  • 00627755056979 ()

  • Height: 57.25 Inch
005XFAN-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755056153

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size 2XL
Lac-Mac Limited
005XH-2XL
In Commercial Distribution

  • 00627755056153 ()

  • Height: 53.5 Inch
  • Width: 31.5 Inch
005XH-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755055972

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XL
Lac-Mac Limited
005XFAN-XL
In Commercial Distribution

  • 00627755055972 ()

  • Height: 56.25 Inch
005XFAN-XL

  • Surgical gown, reusable

Lac-Mac - 00627755055156

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XL
Lac-Mac Limited
005XH-XL
In Commercial Distribution

  • 00627755055156 ()

  • Height: 52.5 Inch
  • Width: 29 Inch
005XH-XL

  • Surgical gown, reusable

Lac-Mac - 00627755054975

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size L
Lac-Mac Limited
005XFAN-L
In Commercial Distribution

  • 00627755054975 ()

  • Height: 54.25 Inch
005XFAN-L

  • Surgical gown, reusable

Lac-Mac - 00627755054159

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size L
Lac-Mac Limited
005XH-L
In Commercial Distribution

  • 00627755054159 ()

  • Height: 51.5 Inch
  • Width: 27.5 Inch
005XH-L

  • Surgical gown, reusable

Lac-Mac - 00627755053978

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size M
Lac-Mac Limited
005XFAN-M
In Commercial Distribution

  • 00627755053978 ()

  • Height: 54.25 Inch
005XFAN-M

  • Surgical gown, reusable

Lac-Mac - 00627755053152

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size M
Lac-Mac Limited
005XH-M
In Commercial Distribution

  • 00627755053152 ()

  • Height: 50.5 Inch
  • Width: 25.5 Inch
005XH-M

  • Surgical gown, reusable

Lac-Mac - 00627755052155

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size S
Lac-Mac Limited
005XH-S
In Commercial Distribution

  • 00627755052155 ()

  • Height: 49.5 Inch
  • Width: 23.5 Inch
005XH-S

  • Surgical gown, reusable

Lac-Mac - 00627755051158

Surgical Gown, Level 4, knit v-neck, ties at waist, grips at neck, patented Size XS
Lac-Mac Limited
005XH-XS
In Commercial Distribution

  • 00627755051158 ()

  • Width: 21.5 Inch
  • Height: 48.5 Inch
005XH-XS

  • Surgical gown, reusable

Respire Pink AT Series,Splint - 06972677871884

No Description
Modern Dental Laboratory (DG) Co., Ltd.
188
In Commercial Distribution

  • 06972677871891 ()
  • 06972677871884 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
  • Orthodontic retainer

Respire Pink AT Series,Retainer - 06972677871860

No Description
Modern Dental Laboratory (DG) Co., Ltd.
186
In Commercial Distribution

  • 06972677871877 ()
  • 06972677871860 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
  • Orthodontic retainer

eIHC IVD bundle AT Turbo-2500 - 00815477020068

Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
LEICA BIOSYSTEMS IMAGING, INC
23ATTIVD-2500
In Commercial Distribution

  • 00815477020068 ()

  • Device Size Text, specify:


  • Multi-modality clinical specimen analysis system IVD

K-ASSAY® Alpha-1 AT Reagent - 00816426020009

For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-001
Not in Commercial Distribution

  • 00816426020009 ()
KAI-001

  • Trypsin-alpha-1-antitrypsin complex (elastase) IVD, reagent

Rotation clamp for fixation at - 04250676733788

operating table, compatible with REF 30-700-00 & 40-337-00
Spiggle & Theis Medizintechnik GmbH
30-700-01
In Commercial Distribution

  • 04250676733788 ()
30-700-01

  • Surgical instrument assist arm system, manually-adjusted

BL 1200 - Labor Mustafa AT - 04038917793278

No Description
Sarstedt Aktiengesellschaft & Co.KG
90.2064.122
In Commercial Distribution

  • 04038917793278 ()
90.2064.122

  • Laboratory container/microscope slide robotic transfer system IVD

CNAP® Monitor 500 at - 09120073930743

SET of: 09120073930750, CNAP® Monitor 500, Main Unit including quick Guide 09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 CNAP® Monitor 500 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 09120073930026, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0 Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073930743 ()
21-FHCN-15500

  • Noninvasive haemodynamic monitoring system

Anti-Mumps Virus AT ELISA (IgG) - 04049016083283

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

InCheck™ AT PATIENT ASSISTANT - 00681490872843

ACCESSORY 9465 ACTIVATOR PAT HND HLD 5L
MEDTRONIC, INC.
9465
Not in Commercial Distribution

  • 00681490872843 ()


  • Cardiac pulse generator reader, home-use

Respire Pink AT Hard/Soft - 00851861007277

Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
RESPIRE MEDICAL HOLDINGS LLC
SPAT020US
In Commercial Distribution

  • 00851861007277 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Luminesse Multilayer Anterior Zirconia AT - D7915147MLATD30

No Description
TALLADIUM, INC.
5147-MLAT-D3
In Commercial Distribution

  • D7915147MLATD30 ()
5147-MLAT-D3

  • Dental appliance fabrication material, ceramic

Luminesse Multilayer Anterior Zirconia AT - D7915147MLATD20

No Description
TALLADIUM, INC.
5147-MLAT-D2
In Commercial Distribution

  • D7915147MLATD20 ()
5147-MLAT-D2

  • Dental appliance fabrication material, ceramic
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