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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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Tray, Sterilization, 10 in x 6 1/2 in x 2 1/2 in
SYMMETRY SURGICAL INC.
20-1006X
Not in Commercial Distribution

  • 00887482144374 ()
20-1006X

  • Instrument tray, reusable
Symmetry® Retractor, Hibbs, 3 in Deep, 1 in Wide, 9 3/4 in
SYMMETRY SURGICAL INC.
23-6381
In Commercial Distribution

  • 00887482045053 ()

  • Length: 9.75 Inch
23-6381

  • Hand-held surgical retractor, reusable
Tray, Perforated Mayo, 17 in x 11 5/8 in x 3/4 in
SYMMETRY SURGICAL INC.
17F-PMT
In Commercial Distribution

  • 00887482057148 ()

  • Length: 17 Inch
  • Width: 11.625 Inch
  • Height: 0.75 Inch
17F-PMT

  • Sterilization stringer
PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40
Ascension Orthopedics, Inc.
OSG20040P
In Commercial Distribution

  • M269OSG20040P1 ()
  • 10381780246442 ()

  • Size 40; 1.250 in L x .966 in outer W x .27 in inner W
OSG-200-40P

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 30
Ascension Orthopedics, Inc.
OSG20030P
In Commercial Distribution

  • M269OSG20030P1 ()
  • 10381780246428 ()

  • Size 30; 1.250 in L x .926 in outer W x .25 in inner W
OSG-200-30P

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 20
Ascension Orthopedics, Inc.
OSG20020P
In Commercial Distribution

  • M269OSG20020P1 ()
  • 10381780246404 ()

  • Size 20; 1.250 in L x .879 in outer W x .23 in inner W
OSG-200-20P

  • Custom-made orthopaedic/craniofacial surgical guide
PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 10
Ascension Orthopedics, Inc.
OSG20010P
In Commercial Distribution

  • M269OSG20010P1 ()
  • 10381780246381 ()

  • Size 10; 1.225 in L x .814 in outer W x .19 in inner W
OSG-200-10P

  • Custom-made orthopaedic/craniofacial surgical guide
Speculum, Sims Vaginal, Double-Ended, #1, 1 in x 2 3/4 in x 1 1/8 in x 3 in
SYMMETRY SURGICAL INC.
52-2001
Not in Commercial Distribution

  • 00887482049860 ()
52-2001

  • Vaginal speculum, reusable
The RONDEX CPR REDI-SHIELD model #9850-G comes in a case with a key ring and gloves. It is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850-G (packaged in key ring case)
In Commercial Distribution

9850-G

  • Cardiopulmonary resuscitation mask, single-use
Integra® External Fixation System The AO t-handle is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
5010001000
In Commercial Distribution

  • M26950100010001 ()
  • 10381780248026 ()

  • 4.399 in L handle
5010001000

  • Surgical instrument handle, non-torque-limiting
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