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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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SpiritMB - 00889989007411

ID W - Twin - Lower-Universal 1st Bicuspid - Pink
ORMCO CORPORATION
495-0615
Not in Commercial Distribution

  • 00889989007411 ()
  • 10889989007418 ()

  • Slot: .022, Torque: -11


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007268

ID Y - Twin - Lower-Universal 2nd Bicuspid-Hook - Pink
ORMCO CORPORATION
494-1725
Not in Commercial Distribution

  • 00889989007268 ()
  • 10889989007265 ()

  • Slot: .018, Torque: -17


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007251

ID W - Twin - Lower-Universal 1st Bicuspid-Hook - Pink
ORMCO CORPORATION
494-1615
Not in Commercial Distribution

  • 00889989007251 ()
  • 10889989007258 ()

  • Slot: .018, Torque: -11


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007138

ID Y - Twin - Lower-Universal 2nd Bicuspid - Pink
ORMCO CORPORATION
494-0725
Not in Commercial Distribution

  • 00889989007138 ()
  • 10889989007135 ()

  • Slot: .018, Torque: -17


  • Orthodontic bracket, plastic, single-use

SpiritMB - 00889989007121

ID W - Twin - Lower-Universal 1st Bicuspid - Pink
ORMCO CORPORATION
494-0615
Not in Commercial Distribution

  • 00889989007121 ()
  • 10889989007128 ()

  • Slot: .018, Torque: -11


  • Orthodontic bracket, plastic, single-use

NA - 03596010196514

UNIVERSAL BIPOLAR LINER 32MM ID 52-56MM OD
Smith & Nephew, Inc.
71323252
Not in Commercial Distribution

  • 03596010196514 ()
71323252

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010196507

UNIVERSAL BIPOLAR LINER 32MM ID 47-51MM OD
Smith & Nephew, Inc.
71323247
Not in Commercial Distribution

  • 03596010196507 ()
71323247

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010196477

UNIVERSAL BIPOLAR LINER 28MM ID 57-60MM OD
Smith & Nephew, Inc.
71322857
Not in Commercial Distribution

  • 03596010196477 ()
71322857

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010196460

UNIVERSAL BIPOLAR LINER 28MM ID 52-56MM OD
Smith & Nephew, Inc.
71322852
Not in Commercial Distribution

  • 03596010196460 ()
71322852

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010196453

UNIVERSAL BIPOLAR LINER 28MM ID 47-51MM OD
Smith & Nephew, Inc.
71322847
Not in Commercial Distribution

  • 03596010196453 ()
71322847

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010196446

UNIVERSAL BIPOLAR LINER 28MM ID 43-46MM OD
Smith & Nephew, Inc.
71322843
Not in Commercial Distribution

  • 03596010196446 ()
71322843

  • Bipolar femoral head outer component, hemiarthroplasty

OPERA - 03596010380241

OPERA CUP LEFT 26MM ID 50MM OD
Smith & Nephew, Inc.
71976134
Not in Commercial Distribution

  • 03596010380241 ()
71976134

  • Polyethylene acetabulum prosthesis

OPERA - 03596010380142

OPERA CUP LEFT 28MM ID 53MM OD
Smith & Nephew, Inc.
71976124
Not in Commercial Distribution

  • 03596010380142 ()
71976124

  • Polyethylene acetabulum prosthesis

OPERA - 03596010380128

OPERA CUP LEFT 28MM ID 50MM OD
Smith & Nephew, Inc.
71976122
Not in Commercial Distribution

  • 03596010380128 ()
71976122

  • Polyethylene acetabulum prosthesis

OPERA - 03596010380104

OPERA CUP LEFT 28MM ID 47MM OD
Smith & Nephew, Inc.
71976120
Not in Commercial Distribution

  • 03596010380104 ()
71976120

  • Polyethylene acetabulum prosthesis

CONVENE - 03596010306869

CONVENE BIPOLAR LINER 28MM ID 52-56MM OD
Smith & Nephew, Inc.
71392852
Not in Commercial Distribution

  • 03596010306869 ()
71392852

  • Bipolar femoral head outer component, hemiarthroplasty

CONVENE - 03596010306852

CONVENE BIPOLAR LINER 28MM ID 47-51MM OD
Smith & Nephew, Inc.
71392847
Not in Commercial Distribution

  • 03596010306852 ()
71392847

  • Bipolar femoral head outer component, hemiarthroplasty

CONVENE - 03596010306838

CONVENE BIPOLAR LINER 26MM ID 38-42MM OD
Smith & Nephew, Inc.
71392638
Not in Commercial Distribution

  • 03596010306838 ()
71392638

  • Bipolar femoral head outer component, hemiarthroplasty

NA - 03596010419835

CERAMIC ACETABULAR LINER IMPACTOR HEAD 32MM ID
Smith & Nephew, Inc.
71369032
In Commercial Distribution

  • 03596010419835 ()
71369032

  • Orthopaedic implant impactor, reusable

CONVENE - 03596010409294

CONVENE BIPOLAR LINER 28MM ID 43-46MM OD
Smith & Nephew, Inc.
71392843
Not in Commercial Distribution

  • 03596010409294 ()
71392843

  • Bipolar femoral head outer component, hemiarthroplasty

CONVENE - 03596010411853

CONVENE BIPOLAR LINER 28MM ID 57-60MM OD
Smith & Nephew, Inc.
71392857
Not in Commercial Distribution

  • 03596010411853 ()
71392857

  • Bipolar femoral head outer component, hemiarthroplasty

GYRUS ACMI - 00821925032514

POPE BEVELED GROMMET 1.14MM ID BLUE POLYETHYLENE
Gyrus ACMI, LLC
70143250
In Commercial Distribution

  • 00821925020603 ()
  • 00821925032514 ()


  • Tympanostomy tube

MAYFIELD® - 10381780257110

.569" OD X .328" ID FLAT WASHER
INTEGRA LIFESCIENCES CORPORATION
GS863
In Commercial Distribution

  • M268GS8631 ()
  • 10381780257110 ()


  • Skull clamp

Standard 64 Sublative iD, (100 Pulse), 10-Pk - 00817495024318

Standard 64 Sublative iD, (100 Pulse), 10-Pk
Candela Corporation
KT72861
In Commercial Distribution

  • 00817495024318 ()
KT72861

  • Multi-modality skin surface treatment system

Standard 64 Sublative iD (200 Pulse) - 00817495023793

Standard 64 Sublative iD, (200 Pulse), Sterile
Candela Corporation
AS79333
In Commercial Distribution



  • Multi-modality skin surface treatment system

5570 3L SYRINGE - 00817136026329

5570 3L SYR HRI BENSON ID TAPR
HANS RUDOLPH, INC.
5570
In Commercial Distribution

  • 00817136026329 ()
113907

  • Spirometer/pulmonary function analyser syringe

5570 3L SYRINGE - 00817136026299

5570 3L CAL SYR 1.375 ID ORING
HANS RUDOLPH, INC.
5570
In Commercial Distribution

  • 00817136026299 ()
113859

  • Spirometer/pulmonary function analyser syringe

8500 3WAY VALVE - 00817136026268

8500B w/200263 1.375" ID ORG ADPT
HANS RUDOLPH, INC.
8500
Not in Commercial Distribution

  • 00817136026268 ()
C149

  • Pulmonary function valve

5530 3L SYRINGE - 00817136026244

3L 5530 SYR NSPIRE 2X ID TPRS
HANS RUDOLPH, INC.
5530
In Commercial Distribution

  • 00817136026244 ()
113845

  • Spirometer/pulmonary function analyser syringe

2700 NRBV - 00817136026213

2700 VLV W/1.375 ID ORING MPC
HANS RUDOLPH, INC.
2700
Not in Commercial Distribution

  • 00817136026213 ()
CR1075

  • Non-rebreathing valve, reusable
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