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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Exactech, Inc.
208-04-71
In Commercial Distribution

  • 10885862053480 ()

  • Size BB
208-04-71

  • Tibial insert
BB
Quality Aspirators, Inc.
BB
In Commercial Distribution

  • 00814005024981 ()
309-10018

  • Dental suction system cannula, reusable
050 35MM NAFION DRYER BB/BB
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106900695 ()
  • 00840106900732 ()
  • 00840106900725 ()
  • 00840106900718 ()
  • 00840106900701 ()
  • 00840106900756 ()
  • 00840106900749 ()
ME-050-03-209

  • Gas-sampling/monitoring respiratory tubing, single-use
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), or large (03) for Baby (BB)
9321-8758 Québec Inc
Ankle Baby
In Commercial Distribution

  • 10628634832018 ()

  • BB S for Baby Small
  • BB M for Medium
  • BB L for Baby Large
TBBC-01, TBBC-02, TBBC-03

  • Custom-made lower-limb orthosis
NPWT Contour Med MAXX Kit
DEROYAL INDUSTRIES, INC.
NP-6007-01
In Commercial Distribution

  • 50749756350490 ()
  • 00749756350495 ()
NP-6007-01

  • Negative-pressure wound therapy system dressing set
MDMG-5221 BB
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001527 ()
K9300520A

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000209 ()
K9301541B

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB
Barco NV
MDCG-5221
Not in Commercial Distribution

  • 05415334000193 ()
K9301541A

  • Radiology picture archiving and communication system workstation
MDNG-5221 BB
Barco NV
MDNG-5221
In Commercial Distribution

  • 05415334000117 ()
K9300351B

  • Radiology picture archiving and communication system workstation
MDNG-5221 BB
Barco NV
MDNG-5221
Not in Commercial Distribution

  • 05415334000100 ()
K9300351A

  • Radiology picture archiving and communication system workstation
BB T-Blade
Surgical Direct, Inc.
SD46028T
In Commercial Distribution

  • B382SD46028T0 ()
SD46028T

  • Self-retaining surgical retractor, reusable
The brace is composed of a low-temperature thermoplastic fused between a layer of 3D stretchable knitted fabric and a layer of 3D stretchable knitted velcro receptive fabric. The brace can be molded directly to the patient to immobilize an elbow with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace. Size small (01), medium (02), large (03), or extra large (04) for Baby (BB)
9321-8758 Québec Inc
Elbow Baby
In Commercial Distribution

  • 10628634832162 ()

  • BB S for baby small
  • BB M for baby medium
  • BB L for baby large
  • BB XL for baby extra large
TBBCo-01, TBBCo-02, TBBCo-03, TBBCo-04

  • Custom-made upper-limb orthosis
A liquid cleansing agent used to remove small debris from plastic aligners
STRAIGHT SMILE LLC
bb
In Commercial Distribution

  • 00850017524064 ()


  • Denture cleanser
Clear Glittered Powder
JBC and Company
bb
In Commercial Distribution

  • D851BB0 ()
bb

  • Dental appliance fabrication material, resin
LifeBubble Buddy (40/case)
NOVONATE INC
BB
In Commercial Distribution

  • 00850002447262 ()
  • 10850002447269 ()
  • 00850002447972 ()
BB

  • Wearable percutaneous catheter/tube holder
Active Ice System Blanket
Polar Products, Inc.
#BB
In Commercial Distribution

  • 00052062003963 ()


  • Circulating-fluid localized thermal therapy system control unit
MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000223 ()
K9301542B

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000216 ()
K9301542A

  • Radiology picture archiving and communication system workstation
MDNG-5221 BB MKIII
Barco NV
MDNG-5221
In Commercial Distribution

  • 05415334030312 ()
K9300351C

  • Radiology picture archiving and communication system workstation
M60, RITE BB
Oticon A/S
104-37-525-00
In Commercial Distribution

  • 05707131146878 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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