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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BTDS ACQUISITION TRANSPORT KIT
DEROYAL INDUSTRIES, INC.
89-10150
In Commercial Distribution

  • 50749756982585 ()
  • 00749756982580 ()
89-10150

  • General surgical procedure kit, non-medicated, single-use
BIRTH TISSUE ACQUISITION PACK
MEDLINE INDUSTRIES, INC.
DYNJ80168A
In Commercial Distribution

  • 10195327453268 ()
DYNJ80168A

  • General surgical procedure kit, non-medicated, single-use
BIRTH TISSUE ACQUISITION PACK
MEDLINE INDUSTRIES, INC.
DYNJ80168B
In Commercial Distribution

  • 10195327644871 ()
DYNJ80168B

  • General surgical procedure kit, non-medicated, single-use
Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin.
JOHN'S DENTAL LABORATORY INC
3014680794
Not in Commercial Distribution

  • 00810002220128 ()


  • CAD/CAM software
  • Dental milling system, CAD/CAM, laboratory
4617 @ARTSPC CAN SET W/DISTAL HOLES & CO
MEDLINE INDUSTRIES, INC.
4617R
In Commercial Distribution

  • 20888277374208 ()
  • 10888277374201 ()
4617R

  • Laparoscopic access cannula, reprocessed
MR Oatient Care Pediatric LoFlo CO/O2 Cannula
SALTER LABS
P183281
In Commercial Distribution

  • 10607411982047 ()
  • 00607411982040 ()
989803183281

  • Nasal oxygen cannula, carbon-dioxide-sampling
PKG,CHG KIT,CO,PREM,MFI,XL,AUS
Gn Hearing A/S
21605600
In Commercial Distribution

  • 05708296197958 ()


  • Noninvasive device battery charger
PKG,CHG KIT,CO,PREM,MFI,XL,US
Gn Hearing A/S
21605200
In Commercial Distribution

  • 05708296197910 ()


  • Noninvasive device battery charger
SPECIAL 8-INSTR SIG,YEL/WHT BASE,BLUE CO
HU-FRIEDY MFG. CO., LLC
IM508528
Not in Commercial Distribution

  • 10889950056537 ()
IM508528

  • Device sterilization/disinfection container, reusable
Personal Use Kit OC-Auto, for Grand Junction, CO
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334490
In Commercial Distribution

  • 00816917022222 ()


  • Faecal occult blood IVD, reagent
*Custom* Wilkes Co IV Start Kit with Saline
BOUND TREE MEDICAL, LLC
8600-01363
In Commercial Distribution

  • 00812277033076 ()
  • 00810094572914 ()
8600-01363

  • Peripheral intravenous catheterization support kit
KUP5 KOIS UNIV CO (M) FL CP 3P
Peter Brasseler Holdings, LLC
5030933U0
In Commercial Distribution

  • 00887919965077 ()


  • Dental abrasive point, reusable
CM-hex screw system Cap screw CO M1.2 short
Cendres+Métaux SA
05000120
In Commercial Distribution

  • 07640166514961 ()
05000120

  • Dental prosthesis/implant abutment screw
Widal & Weil Felix Positive control Salmonella Paratyphi C-O
PRO-LAB, INCORPORATED
PLA585
In Commercial Distribution

  • 00817978025856 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
Salmonella Paratyphi C-O Widal and Weil Felix Antigen
PRO-LAB, INCORPORATED
PLA303
In Commercial Distribution

  • 00817978023036 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
CM-hex screw system Cap screw CO M1.4 short
Cendres+Métaux SA
05000122
In Commercial Distribution

  • 07640173090076 ()

  • Length: 6.20 Millimeter
05000122

  • Dental prosthesis/implant abutment screw
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/60
In Commercial Distribution

  • 04026575302253 ()
645-075/60

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/50
In Commercial Distribution

  • 04026575302239 ()
645-075/50

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/60
In Commercial Distribution

  • 04026575302215 ()
645-073/60

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/50
In Commercial Distribution

  • 04026575302192 ()
645-073/50

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/35
In Commercial Distribution

  • 04026575240685 ()
645-075/35

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/30
In Commercial Distribution

  • 04026575240678 ()
645-075/30

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/25
In Commercial Distribution

  • 04026575240661 ()
645-075/25

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/20
In Commercial Distribution

  • 04026575240654 ()
645-075/20

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/40
In Commercial Distribution

  • 04026575240647 ()
645-073/40

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/35
In Commercial Distribution

  • 04026575240630 ()
645-073/35

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/30
In Commercial Distribution

  • 04026575240579 ()
645-073/30

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/25
In Commercial Distribution

  • 04026575240524 ()
645-073/25

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-073/20
In Commercial Distribution

  • 04026575240517 ()
645-073/20

  • Orthopaedic bone screw (non-sliding)
Bone Screws, and Central Cancellous Bone Screw, Co
WALDEMAR LINK GmbH & Co. KG
645-075/40
In Commercial Distribution

  • 04026575240692 ()
645-075/40

  • Orthopaedic bone screw (non-sliding)
357.404 @TAPERED DRL BIT CANTED LG QK CO
MEDLINE INDUSTRIES, INC.
357404RH
In Commercial Distribution

  • 10888277356160 ()
357404RH

  • Cannulated surgical drill bit, single-use
OR CLN UP KIT VAN MERT CO HOSP
MEDLINE INDUSTRIES, INC.
DYK1016081C2
In Commercial Distribution

  • 10884389349045 ()
DYK1016081C2

  • General surgical procedure kit, non-medicated, reusable
Co. Cr. Base Plastic Castable Abut, Pl.+Co.Cr.
NORIS MEDICAL LTD
NM-C2002
Not in Commercial Distribution

  • 07290108816457 ()
NM-C2002

  • Dental implant suprastructure, temporary, preformed, single-use
A portable, non-invasive cardiac output (CO) monitoring device.
CHEETAH MEDICAL (ISRAEL) LTD
CMM-ST5
Not in Commercial Distribution

  • 07290013030030 ()
CMM-ST5

  • Multiple vital physiological parameter monitoring system, clinical
White/Green Co Braid Size 3.5mm 30" Medshape
TELEFLEX INCORPORATED
IPN001120
In Commercial Distribution

  • 24026704713756 ()
  • 14026704713759 ()
1700-02-000

  • Polyolefin/fluoropolymer suture, multifilament
White/Green Co Braid Size 3.5mm 30" Medshape
TELEFLEX INCORPORATED
IPN001120
In Commercial Distribution

  • 24026704596397 ()
  • 14026704596390 ()

  • Suture Length 30"
1700-02-000

  • Polyolefin/fluoropolymer suture, multifilament
No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD
Jumbo Flood Phantom
PINESTAR TECHNOLOGY, INC.
NMC-76801
In Commercial Distribution

  • 00850021301460 ()


  • Nuclear medicine phantom, flood source
Flood Phantom
PINESTAR TECHNOLOGY, INC.
76-801
In Commercial Distribution

  • 00850021301453 ()


  • Nuclear medicine phantom, flood source
No Description
Sanders Medical Products, Inc.
PET-LINE
In Commercial Distribution

  • 00850055164017 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
NER8410
In Commercial Distribution

  • 00810117211301 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
A3407-3
In Commercial Distribution

  • 00810117211295 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
B003564
In Commercial Distribution

  • 00810117211288 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
B003022
In Commercial Distribution

  • 00810117211271 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
B003021
In Commercial Distribution

  • 00810117211264 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
B003019
In Commercial Distribution

  • 00810117211257 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
B002788
In Commercial Distribution

  • 00810117211240 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
S3434-1
In Commercial Distribution

  • 00810117211233 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
A3430
In Commercial Distribution

  • 00810117211226 ()


  • Nuclear medicine phantom, line source
Attenuation Correction Line Source
Eckert & Ziegler Isotope Products, Inc.
A3418-2
In Commercial Distribution

  • 00810117211219 ()


  • Nuclear medicine phantom, line source
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