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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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Symmetry® Retractor, Kelly, 1 1/2 in x 2 in, Standard Handle, 10 1/4 in
SYMMETRY SURGICAL INC.
52-2513
In Commercial Distribution

  • 00887482172803 ()

  • Length: 10.75 Inch
52-2513

  • Surgical retractor/retraction system blade, reusable
Symmetry® Tray, Sterilizing, 11 1/4 in x 11 1/4 in x 3 in, Small
SYMMETRY SURGICAL INC.
21-3000
In Commercial Distribution

  • 00887482001073 ()

  • Length: 11.25 Inch
  • Width: 11.25 Inch
  • Height: 3 Inch
21-3000

  • Instrument tray, reusable
Symmetry® Retractor, Taylor Spinal, 1 1/4 in Wide, 6 in Deep, 6 3/4 in
SYMMETRY SURGICAL INC.
57-5413
In Commercial Distribution

  • 00887482098202 ()

  • Length: 6.75 Inch
57-5413

  • Hand-held surgical retractor, reusable
Symmetry® Retractor, Taylor Spinal, 1 1/4 in Wide, 4 in Deep, 7 1/4 in
SYMMETRY SURGICAL INC.
57-5410
In Commercial Distribution

  • 00887482098196 ()

  • Length: 7.25 Inch
  • Width: 1.25 Inch
  • Depth: 4 Inch
57-5410

  • Surgical retractor/retraction system blade, reusable
Symmetry® Retractor, Taylor Spinal, 1 1/4 in Wide, 3 in Deep, 7 1/4 in
SYMMETRY SURGICAL INC.
57-5407
In Commercial Distribution

  • 00887482098172 ()

  • Length: 7.25 Inch
  • Width: 1.25 Inch
  • Depth: 3 Inch
57-5407

  • Hand-held surgical retractor, reusable
Titan™ Total Shoulder System The glenoid peg punch is used to check hole positioning/depth, in addition to being used as a cement pressurizer. The glenoid peg punch can be utilized to impact the graft.
Ascension Orthopedics, Inc.
PN0920072002
In Commercial Distribution

  • M269PUN09200720021 ()
  • 10381780246756 ()

  • Size Medium/Large; 1.45 in L x 1.06 in W punch
PUN-0920-072-002

  • Bone cutter
Integra® Total Foot System The glenoid peg punch is used to check hole positioning/depth, in addition to being used as a cement pressurizer. The glenoid peg punch can be utilized to impact the graft.
Ascension Orthopedics, Inc.
PN0920072001
In Commercial Distribution

  • M269PUN09200720011 ()
  • 10381780246749 ()

  • Size X-Small/ Small; 1.25 in L x .90 in W punch
PUN-0920-072-001

  • Bone cutter
Integra® Total Foot System The glenoid keeled punch is used to impact the bone in the glenoid fossa for proper fit of the glenoid keel trial. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN0920062002
In Commercial Distribution

  • M269PUN09200620021 ()
  • 10381780246732 ()

  • Size Medium/Large; 1.45 in L x 1.06 in W punch
PUN-0920-062-002

  • Bone cutter
Titan™ Total Shoulder System The glenoid keeled punch is used to impact the bone in the glenoid fossa for proper fit of the glenoid keel trial. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN0920062001
In Commercial Distribution

  • M269PUN09200620011 ()
  • 10381780246725 ()

  • Size X-Small/ Small; 1.25 in L x .90 in W punch
PUN-0920-062-001

  • Bone cutter
First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829127065 ()


  • Skin-cover adhesive strip, non-antimicrobial
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