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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Skin Surface Temperature Probe Reusable; stainless steel disc; epoxy backing; size = 3/8" (9.5mm); length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Skin Surface Temperature Probe
Not in Commercial Distribution

  • 00884838001015 ()
21078A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838001008 ()
21076A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838000995 ()
21075A

  • General-purpose patient temperature probe, reusable
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution

  • 00860000603805 ()


  • Ophthalmic tonometer tip cover
LeadCare® Blood Lead Control Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare®
In Commercial Distribution

  • 00850355006161 ()
70-3440

  • Lead (Pb) analyser IVD
TRAY,CATHETER,INTERMITTENT,14F,STERIL
MEDLINE INDUSTRIES, INC.
DYNDT1041
In Commercial Distribution

  • 40884389228679 ()
  • 10884389228678 ()
DYNDT1041

  • Indwelling urethral catheterization kit, adult
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0724
In Commercial Distribution

  • 10811503033528 ()
NP377SS0724

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0726
In Commercial Distribution

  • 10811503033511 ()
NP377SS0726

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0724
In Commercial Distribution

  • 10811503033481 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0726
In Commercial Distribution

  • 10811503033474 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SP0728
In Commercial Distribution

  • 10811503033436 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0828
In Commercial Distribution

  • 10811503033429 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377ER0830
In Commercial Distribution

  • 10811503033412 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0826
In Commercial Distribution

  • 10811503033405 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SL7526
In Commercial Distribution

  • 10811503033399 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0724
In Commercial Distribution

  • 10811503033382 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP330SP0626
In Commercial Distribution

  • 10811503033375 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0726
In Commercial Distribution

  • 10811503033368 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0728
In Commercial Distribution

  • 10811503033337 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0726
In Commercial Distribution

  • 10811503033320 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SP0726
In Commercial Distribution

  • 10811503033313 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SP0724
In Commercial Distribution

  • 10811503033306 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SH0726
In Commercial Distribution

  • 10811503033276 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SH0724
In Commercial Distribution

  • 10811503033269 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SH0726
In Commercial Distribution

  • 10811503033252 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SH0724
In Commercial Distribution

  • 10811503033245 ()


  • Polymeric ureteral stent
The VERIFY Chemical Integrating Indicators monitor all critical parameters of steam sterilization (time, temperature and steam quality).
STERIS CORPORATION
PCC039
Not in Commercial Distribution

  • 10724995095557 ()
  • 00724995095550 ()
PCC039

  • Chemical/physical sterilization process indicator
Lot number, Expiration Date, Individual Kit Number, Temperature Range and the statement: The Conception Kit should be kept away from direct sunlight, moisture and heat.
CONCEIVEX INC.
CX-0002-ML EN/ES
In Commercial Distribution

  • 00895863001000 ()

  • Wide 9 inches
  • lenght 10 inches
  • Height: 6 .5 inches
CX-0002-ML EN/ES

  • Natural conception assistance kit
No-Mix Orthodontic Adhesive (Primer-Activated) Mini Kit
ORTHO ORGANIZERS, INC.
490-350
Not in Commercial Distribution

  • 00190707000325 ()


  • Orthodontic bracket adhesive
No-Mix Adhesive Syringe
ORTHO ORGANIZERS, INC.
490-114
Not in Commercial Distribution

  • 00190707000141 ()


  • Orthodontic bracket adhesive
Primer-Activated Syringe 3.5gm per syringe
ORTHO TECHNOLOGY, INC.
FC-RESI-024
In Commercial Distribution

  • 00190730000262 ()


  • Orthodontic bracket adhesive
Primer-Activated Intro Kit 3.5gm syringe and 3mL primer
ORTHO TECHNOLOGY, INC.
FC-RESI-012SK
In Commercial Distribution

  • 00190730000224 ()


  • Orthodontic bracket adhesive
Primer-Activated Syringe Kit 4x 3.5gm syringes
ORTHO TECHNOLOGY, INC.
FC-RESI-012
In Commercial Distribution

  • 00190730000217 ()


  • Orthodontic bracket adhesive
Paste/Paste Ionomer Econo Kit 4x 5gm base/4x 5gm catalyst
ORTHO TECHNOLOGY, INC.
FC-GRAN-061
In Commercial Distribution

  • 00190730000170 ()


  • Glass ionomer dental cement
Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
1000003
Not in Commercial Distribution

  • 20015482100036 ()
  • 10015482100039 ()
  • 00015482100032 ()


  • Pill swallowing lubricant
Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
1000002
Not in Commercial Distribution

  • 20015482100029 ()
  • 10015482100022 ()
  • 00015482100025 ()


  • Pill swallowing lubricant
Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.)
ARKRAY USA, INC.
502005
In Commercial Distribution

  • 00015482502058 ()


  • Glucose IVD, control
Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.)
ARKRAY USA, INC.
502004
In Commercial Distribution

  • 00015482502041 ()


  • Glucose IVD, control
Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
500006
In Commercial Distribution

  • 00015482500061 ()


  • Glucose IVD, control
Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500054 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
500005
In Commercial Distribution

  • 00015482500054 ()


  • Glucose IVD, control
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site.
MINIMALLY INVASIVE DEVICES, INC.
FX10
In Commercial Distribution

  • 00815128020652 ()
  • 10815128020659 ()

  • Total Volume: 10 Milliliter
FX10

  • Endoscope antifog solution
61301658261 - Bag of 250 Integrators 61301600556 - Bag of 100 Integrators
STERITEC PRODUCT MFG. CO., INC.
61301658261, 61301600556
In Commercial Distribution

  • 20814434020589 ()
  • 00814434020585 ()
  • 10814434020582 ()
61301658261, 61301600556

  • Chemical/physical sterilization process indicator
Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
Not in Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use
Filter-Manifold to Collect Fluids from four suction fields and filter non-liquids. Package of 12.
M D Technologies Inc.
FM99
Not in Commercial Distribution

  • B325FM990 ()
  • B325FM991 ()
FM99

  • Surgical suction system collection container, single-use
Health-Tec Universal Bond 5ml
Dental Health Products Inc
220-HT60B
In Commercial Distribution

  • D773220HT60B1 ()

  • Total Volume: 5 Milliliter
220-HT60B

  • Dentine bonding agent/set
Health-Tec/DHP Refrigerant Spray 6oz. Can
Dental Health Products Inc
330-10005
In Commercial Distribution

  • D773330100050 ()
330-10005

  • Cryogenic spray, dental
Strep A Test CLIA Waived 25/Box
DEALMED MEDICAL SUPPLIES LLC
788025
In Commercial Distribution

  • 00817415020307 ()
  • 00817415020963 ()
788025

  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
Scrip Hessco Creme All Purpose Lotion 1 Gallon
Scriphessco
663 0019
In Commercial Distribution

  • 00812433029295 ()


  • Skin topical coupling gel
Ureteral Stent
Q UROLOGICAL CORPORATION
NP377SS0726
In Commercial Distribution

  • 00811503033514 ()
NP377SS0726

  • Polymeric ureteral stent
Ureteral Stent
Q UROLOGICAL CORPORATION
NP378SS0724
In Commercial Distribution

  • 00811503033484 ()


  • Polymeric ureteral stent
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