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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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ONETRAC - M648C1001100

Retractor 135X30mm with Built-In Single-Use Light Source - STERILE
OBP CORPORATION
C100110
In Commercial Distribution

  • M648C1001102 ()
  • M648C1001101 ()
  • M648C1001100 ()
C100110

  • Abdominal retractor, hand-held

SURE-SCOPE - M648C0902300

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 3
OBP CORPORATION
C090230
In Commercial Distribution

  • M648C0902302 ()
  • M648C0902301 ()
  • M648C0902300 ()
C090230

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0902200

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 2
OBP CORPORATION
C090220
In Commercial Distribution

  • M648C0902202 ()
  • M648C0902201 ()
  • M648C0902200 ()
C090220

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0902100

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 1
OBP CORPORATION
C090210
In Commercial Distribution

  • M648C0902102 ()
  • M648C0902101 ()
  • M648C0902100 ()
C090210

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0902050

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 00
OBP CORPORATION
C090205
In Commercial Distribution

  • M648C0902052 ()
  • M648C0902051 ()
  • M648C0902050 ()
C090205

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0902000

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 0
OBP CORPORATION
C090200
In Commercial Distribution

  • M648C0902002 ()
  • M648C0902001 ()
  • M648C0902000 ()
C090200

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0901400

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MAC 4
OBP CORPORATION
C090140
In Commercial Distribution

  • M648C0901402 ()
  • M648C0901401 ()
  • M648C0901400 ()
C090140

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0901300

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MAC 3
OBP CORPORATION
C090130
In Commercial Distribution

  • M648C0901302 ()
  • M648C0901301 ()
  • M648C0901300 ()
C090130

  • Rigid intubation laryngoscope, reusable

SURE-SCOPE - M648C0901200

SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MAC 2
OBP CORPORATION
C090120
In Commercial Distribution

  • M648C0901202 ()
  • M648C0901201 ()
  • M648C0901200 ()
C090120

  • Rigid intubation laryngoscope, reusable

ANOSPEC - M648C0601200

103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE
OBP CORPORATION
C060120
In Commercial Distribution

  • M648C0601202 ()
  • M648C0601201 ()
  • M648C0601200 ()
C060120

  • Optical anoscope, single-use

ANOSPEC - M648C0601100

96mm x 23mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE
OBP CORPORATION
C060110
In Commercial Distribution

  • M648C0601102 ()
  • M648C0601101 ()
  • M648C0601100 ()
C060110

  • Optical anoscope, single-use

ANOSPEC - M648C0601000

90mm x 18mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE
OBP CORPORATION
C060100
In Commercial Distribution

  • M648C0601002 ()
  • M648C0601001 ()
  • M648C0601000 ()
C060100

  • Optical anoscope, single-use

FLUID MANAGEMENT PACK - M648C0501000

No Description
OBP CORPORATION
C050100
In Commercial Distribution

  • M648C0501002 ()
  • M648C0501001 ()
  • M648C0501000 ()
C050100

  • Urological surgical procedure kit, medicated, single-use

HER-SPEC - M648C0206200

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE - STERILE
OBP CORPORATION
C020620
In Commercial Distribution

  • M648C0206202 ()
  • M648C0206201 ()
  • M648C0206200 ()


  • Vaginal speculum, single-use

HER-SPEC - M648C0206100

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM - STERILE
OBP CORPORATION
C020610
In Commercial Distribution

  • M648C0206102 ()
  • M648C0206101 ()
  • M648C0206100 ()


  • Vaginal speculum, single-use

HER-SPEC - M648C0206000

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL - STERILE
OBP CORPORATION
C020600
In Commercial Distribution

  • M648C0206002 ()
  • M648C0206001 ()
  • M648C0206000 ()


  • Vaginal speculum, single-use

HER-SPEC - M648C0205200

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE
OBP CORPORATION
C020520
In Commercial Distribution

  • M648C0205202 ()
  • M648C0205201 ()
  • M648C0205200 ()


  • Vaginal speculum, single-use

HER-SPEC - M648C0205100

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM
OBP CORPORATION
C020510
In Commercial Distribution

  • M648C0205102 ()
  • M648C0205101 ()
  • M648C0205100 ()


  • Vaginal speculum, single-use

HER-SPEC - M648C0205000

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL
OBP CORPORATION
C020500
In Commercial Distribution

  • M648C0205002 ()
  • M648C0205001 ()
  • M648C0205000 ()


  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C0203200

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE - STERILE
OBP CORPORATION
C020320
In Commercial Distribution

  • M648C0203202 ()
  • M648C0203201 ()
  • M648C0203200 ()
C020320

  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C0203100

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM - STERILE
OBP CORPORATION
C020310
In Commercial Distribution

  • M648C0203102 ()
  • M648C0203101 ()
  • M648C0203100 ()
C020310

  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C0203000

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL - STERILE
OBP CORPORATION
C020300
In Commercial Distribution

  • M648C0201202 ()
  • M648C0203001 ()
  • M648C0203000 ()
C020300

  • Vaginal speculum, single-use

ER-SPEC - M648C02014010

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA LARGE
OBP CORPORATION
C020140-1
In Commercial Distribution

  • M648C02014012 ()
  • M648C02014011 ()
  • M648C02014010 ()


  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C02013010

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA SMALL
OBP CORPORATION
C020130-1
In Commercial Distribution

  • M648C02013012 ()
  • M648C02013011 ()
  • M648C02013010 ()


  • Vaginal speculum, single-use

ER-SPEC/OFFICESPEC - M648C02012010

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE LARGE
OBP CORPORATION
C020120-1
In Commercial Distribution

  • M648C02012012 ()
  • M648C02012011 ()
  • M648C02012010 ()
C020120-1

  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C02011010

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM
OBP CORPORATION
C020110-1
In Commercial Distribution

  • M648C02011012 ()
  • M648C02011011 ()
  • M648C02011010 ()
C020110-1

  • Vaginal speculum, single-use

ER-SPEC/OFFICE-SPEC - M648C02010010

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE SMALL
OBP CORPORATION
C020100-1
In Commercial Distribution

  • M648C02010012 ()
  • M648C02010011 ()
  • M648C02010010 ()
C020100-1

  • Vaginal speculum, single-use

OFFICESPEC - M648C0200010

SINGLE-SIDED VAGINAL SPECULUM WITH LIGHT SINGLE-USE SIZE MEDIUM
OBP CORPORATION
C020001
In Commercial Distribution

  • M648C0200012 ()
  • M648C0200011 ()
  • M648C0200010 ()
C020001

  • Vaginal speculum, single-use

TracLux - M678TLCSLS0

TracLux SLS-S, Battery Operated Lightsource
SUNOPTIC TECHNOLOGIES LLC
TracLux-SLS
In Commercial Distribution

  • M678TLCSLS0 ()
  • M678TLCSLS1 ()
  • M678TLCSLS3 ()
TLC1353-SLSU

  • Open surgical site internal light

TRACLUX - M678TLC0

TRACLUX Light Carrier, Sterile, Single Use, and accessories
SUNOPTIC TECHNOLOGIES LLC
TLC
In Commercial Distribution

  • M678TLC0 ()
  • M678TLC1 ()
  • M678TLC3 ()
TLC2575, TLC25150, TLC1353-U

  • Open surgical site internal light

Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer - M678SLSS0

Battery powered light source for illumination of a surgical field.
SUNOPTIC TECHNOLOGIES LLC
ROVER SLS
In Commercial Distribution

  • M678SLSS0 ()
  • M678SLSS1 ()
  • M678SLSS3 ()
ROVER SLS-S

  • Open surgical site internal light

ResQCPR System - M5921208250001

The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual

ResQPOD ITD 10 - M5921202420000

The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory

Sutrasilk - M583VS840821

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: double arm
VISIONARY MEDICAL SUPPLIES INC
VS84082
In Commercial Distribution

  • M583VS840823 ()
  • M583VS840822 ()
  • M583VS840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 40 Centimeter


  • Silk suture

Sutrasilk - M583VS840811

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: single arm
VISIONARY MEDICAL SUPPLIES INC
VS84081
In Commercial Distribution

  • M583VS840813 ()
  • M583VS840812 ()
  • M583VS840811 ()

  • Length: 40 Centimeter
  • Length: 6.0 Millimeter
  • Outer Diameter: 0.20 Millimeter
  • 8-0 USP
  • Angle: 140 degree


  • Silk suture

Sutrasilk - M583S840821

8-0 Suture USP / Thread Specifications: Silk, Black Braided, 12 inch (30 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 circle (140 degrees), length 6 mm, wire 0.20mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S84082
In Commercial Distribution

  • M583S840823 ()
  • M583S840822 ()
  • M583S840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 30 Centimeter


  • Silk suture

Sutrasilk - M583S74092TP1

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: TP-140-9, Taper Point, 3/8 circle (140 degrees), length 9.0 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092TP
In Commercial Distribution

  • M583S74092TP3 ()
  • M583S74092TP2 ()
  • M583S74092TP1 ()

  • Angle: 140 degree
  • 7-0 USP
  • Outer Diameter: 0.23 Millimeter
  • Length: 9.0 Millimeter
  • Length: 45 Centimeter


  • Silk suture

Sutrasilk - M583S740921

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092
In Commercial Distribution

  • M583S740923 ()
  • M583S740922 ()
  • M583S740921 ()

  • Angle: 140 degree
  • Length: 45 Centimeter
  • Length: 6.6 Millimeter
  • Outer Diameter: 0.23 Millimeter
  • 7-0 USP


  • Silk suture

Sutrasilk - M583S6401121

6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 circle (140 degrees), length 8.0 mm, wire 0.28mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S640112
In Commercial Distribution

  • M583S6401123 ()
  • M583S6401122 ()
  • M583S6401121 ()

  • Angle: 140 degree
  • 6-0 USP
  • Outer Diameter: 0.28 Millimeter
  • Length: 8.0 Millimeter
  • Length: 76 Centimeter


  • Silk suture

Sutrasilk - M583S440171C1

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of needles: Single arm
VISIONARY MEDICAL SUPPLIES INC
S440171C
In Commercial Distribution

  • M583S440171C3 ()
  • M583S440171C2 ()
  • M583S440171C1 ()

  • Angle: 140 degree
  • 4-0 USP
  • Outer Diameter: 0.43 Millimeter
  • Length: 15.9 Millimeter
  • Length: 76 Centimeter


  • Silk suture
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