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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No Description
ALYK, INC.
Personal Lubricant - .COM
In Commercial Distribution

  • 00851617007872 ()


  • General-body orifice lubricant, non-sterile
No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser
Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA90X39SUP
In Commercial Distribution

  • 00868680000310 ()
  • 10868680000317 ()
OSA90X39SUP

  • External circulating-air core temperature regulation system pad, single-use
Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA96X39LIT
In Commercial Distribution

  • 10868680000300 ()
  • 00868680000303 ()
  • 20868680000307 ()
OSA96X39LIT

  • External circulating-air core temperature regulation system pad, single-use
The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Retainium Lingual retainer wires and Technical Bonding Cards
RELIANCE ORTHODONTIC PRODUCTS INC
EUUNIVHAND
In Commercial Distribution

  • D798EUUNIVHAND0 ()
EUUNIVHAND

  • Orthodontic bracket adhesive
  • Dentine bonding agent/set
  • Orthodontic wire
The University College Kit includes 1 syringe Ultra Band Lok Blue, 1 syringe Light Bond bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Bond A Braid Lingual retainer wires and Technical Bonding Cards
RELIANCE ORTHODONTIC PRODUCTS INC
UNIVHAND14
Not in Commercial Distribution

  • D798UNIVHAND140 ()
UNIVHAND14

  • Orthodontic wire
  • Dentine bonding agent/set
  • Orthodontic bracket adhesive
Content: 1. Bone conductor calibrated (Sentiero) AN100909 2. Gooseneck microphone AN100779 3. FW Live AN100825 4. UT-08 Spondee Words for Children (English) AN100819 5. UT-10 Spondee Words for Adults (English) AN100821 6. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 7. UT-12 Central Institute for the Deaf Auditory Test W22 (English) AN100823 8. UT-13 PBK-50 (English) AN100824
PATH medical GmbH
100780-B
In Commercial Distribution

  • 04260223141744 ()


  • Evoked-potential audiometer
No Description
Natus Medical Denmark ApS
1096, PC CLINICAL COM US
In Commercial Distribution

  • 05713315005589 ()
8-04-16034

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096, PC, DIAGNOSTIC, COM, US
In Commercial Distribution

  • 05713315005558 ()
8-04-16031

  • Impedance audiometer
No Description
MICROPORT CRM SRL
V3.10 UPG TO USB COM
In Commercial Distribution

  • 08031527014944 ()


  • Electrocardiographic long-term ambulatory recording analyser
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