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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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Integra® Miltex® - 10381780418498

Integra® Miltex® Nugent Utility Forceps 4-3/8", Angled Jaws, Smooth, 1.2mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-956
In Commercial Distribution

  • H834189560 ()
  • 10381780418498 ()

  • Width: 1.2 Millimeter
  • 4-3/8"
18-956

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Integra® Miltex® - 10381780418184

Integra® Miltex® Strabismus Forceps 4", Straight, 1 x 2 Teeth, 1mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-840
In Commercial Distribution

  • H834188400 ()
  • 10381780418184 ()
18-840

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Integra® Miltex® - 10381780418078

Integra® Miltex® Gill (Chandler) Iris Forceps 2-7/8", Curved, Cross-Serrated, 0.5mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-825
In Commercial Distribution

  • H834188250 ()
  • 10381780418078 ()
18-825

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Pointe Scientific, Inc. - 00811727012524

Albumin Reagent Set for the quantitative determination of Albumin in serum. Packaged at 14 x 100ml
POINTE SCIENTIFIC, INC.
HA901-1400
In Commercial Distribution

  • 00811727012524 ()
HA901-1400

  • Albumin IVD, kit, spectrophotometry

Surgical Direct - B382SD918660000

6" Beck Vascular Clamp, Cooley Jaws, Calibrated at 5.0mm Intervals, Straight Shanks, Large Jaw, Medium Curve
Surgical Direct, Inc.
SD91866000
In Commercial Distribution

  • B382SD918660000 ()
SD91866000

  • Dressing/utility forceps, scissors-like, reusable

OPTIFIX - 00801741136566

OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 30 Fasteners
Davol Inc.
0113330
In Commercial Distribution

  • 10801741136563 ()
  • 00801741136566 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113330

  • Soft-tissue/mesh anchor, bioabsorbable

OPTIFIX - 00801741136559

OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners
Davol Inc.
0113315
In Commercial Distribution

  • 10801741136556 ()
  • 00801741136559 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113315

  • Soft-tissue/mesh anchor, bioabsorbable

Provox FenestrationPunch - 07331791002632

The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.
Atos Medical AB
7654
Not in Commercial Distribution

  • 07331791002632 ()
7654

  • Tracheostomy tube, non-reinforced, non-customized, reusable

Diamatrix - 00813059017055

Bishop-Harmon Cannula, 19 Gauge, Angled 30° at 5mm from bend to spatulated tip, 25mm tip length
Diamatrix
C191
In Commercial Distribution

  • 00813059017055 ()
C191

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Diamatrix - 00813059014962

Bishop-Harmon Cannula, 19 Gauge, Angled 35° at 7mm from bend to spatulated tip, 24mm tip length
Diamatrix
C190-19
In Commercial Distribution

  • 00813059014962 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

RENASYS EDGE - 05000223501129

RENASYS EDGE Carry Bag
SMITH & NEPHEW MEDICAL LIMITED
66803136
In Commercial Distribution

  • 05000223501136 ()
  • 05000223501129 ()

  • 172x135 x134W x H x Dmm (approximate dimensions with strap at longest)
66803136

  • Negative-pressure wound therapy system, electric, reusable

MR PHACO - G412PH60040

Crestpoint Mr. Phaco Mackool Maxicurve Big Ball Chopper (horizontal) DBL-Ended 0.6mm Mackool ball shaped tip with C-shaped curved shaft, Angled 10mm at 45* / Cylindrical Spatula, slightly vaulted 11.5mm at 50*, short round knurled handle, Stainless Steel
Crestpoint Management Limited
PH6004
In Commercial Distribution

  • G412PH60040 ()


  • Soft-tissue surgical hook, reusable

MR PHACO - G412CA7900

Sheets Irrigation Vectis 20ga loop with with 14ga Reinforced shaft, Angled 19mm from bend to tip at 20 degrees, Three Outer Irrigating Ports at 12, 9, and 3 o'clock, Serrated on top of Vectus, 38mm Overall Length
Crestpoint Management Limited
CA790
In Commercial Distribution

  • G412CA7900 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

LZ30 - 00852116008209

Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxIR
In Commercial Distribution

  • 00852116008209 ()


  • Musculoskeletal/physical therapy laser, professional

LZ30 - 00852116008193

Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxR
In Commercial Distribution

  • 00852116008193 ()


  • Musculoskeletal/physical therapy laser, professional

LZ30 - 00852116008049

Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProIR
Not in Commercial Distribution

  • 00852116008049 ()


  • Musculoskeletal/physical therapy laser, professional

LZ30 - 00852116008032

Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProR
Not in Commercial Distribution

  • 00852116008032 ()


  • Musculoskeletal/physical therapy laser, professional

MSI Precision Specialty Instruments - 00194613061852

Chandler Elevator Blunt 8mm Width At Tip 13mm Maximum Width With Overall Length 7 1/2" (191mm)
Med Saver, Inc.
D6250
In Commercial Distribution

  • 00194613061852 ()


  • Bone lever/elevator, reusable

MSI Precision Specialty Instruments - 00194613093587

Silverstein Round Disk Knife 2mm In Diameter Head Angled At 33 Degrees Up Overall Length 7.1" (180mm)
Med Saver, Inc.
114-2817-S10
In Commercial Distribution

  • 00194613093587 ()


  • Nasal knife

MSI Precision Specialty Instruments - 00194613080044

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 6 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9118
In Commercial Distribution

  • 00194613080044 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613080037

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 5 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9117
In Commercial Distribution

  • 00194613080037 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613080020

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 4 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9116
In Commercial Distribution

  • 00194613080020 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613080013

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 3 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9115
In Commercial Distribution

  • 00194613080013 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613080006

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 00 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9111
In Commercial Distribution

  • 00194613080006 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613112264

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 2 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9114
In Commercial Distribution

  • 00194613112264 ()


  • Bone curette, reusable

MSI Precision Specialty Instruments - 00194613111991

Brun (Spratt) Curette With Hollow Handle Oval Cup Size 0 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9112
In Commercial Distribution

  • 00194613111991 ()


  • Bone curette, reusable

Promax Surgical Gown - 00634916825381

Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size XXL
STANDARD TEXTILE CO., INC.
75675213
In Commercial Distribution

  • 10634916825388 ()
  • 00634916825381 ()


  • Surgical gown, reusable

Promax Surgical Gown - 00634916825374

Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size X-Large
STANDARD TEXTILE CO., INC.
75675214
In Commercial Distribution

  • 10634916825371 ()
  • 00634916825374 ()


  • Surgical gown, reusable

Promax Surgical Gown - 00634916825367

Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size Large
STANDARD TEXTILE CO., INC.
75675215
In Commercial Distribution

  • 10634916825364 ()
  • 00634916825367 ()


  • Surgical gown, reusable

Gimmi - 04049047103899

HASSON AUTOM. TROCAR W. SUTUREHOLDER FIXED AT CONE 11 MM, STOP-COCK FOR INSUFFLATION, TROCAR MANDRIN BLUNT TIP
Gimmi GmbH
T.8014.41
In Commercial Distribution

  • 04049047103899 ()
T.8014.41

  • Laparoscopic access cannula, reusable

Gimmi - 04049047103875

HASSON AUTOM. TROCAR W. SUTUREHOLDER FIXED AT CONE 5.5 MM, STOP-COCK FOR INSUFFLATION, TROCAR MANDRIN BLUNT TIP
Gimmi GmbH
T.8014.36
In Commercial Distribution

  • 04049047103875 ()
T.8014.36

  • Laparoscopic access cannula, reusable

Exchangeable suction-Irrigation tube - 04048223029541

Exchangeable suction-Irrigation tube M8 x 1, Ø 10mm, markings and 4 holes at distal end OlympusID: A5797
Pajunk GmbH Medizintechnologie
1298-00-10OL
Not in Commercial Distribution

  • 04048223029541 ()
1298-00-10OL

  • Laparoscopic access cannula, reusable

Exchangeable suction-Irrigation tube - 04048223029534

Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end Olympus-ID: A5798
Pajunk GmbH Medizintechnologie
1298-00-05OL
Not in Commercial Distribution

  • 04048223029534 ()
1298-00-05OL

  • Laparoscopic access cannula, reusable

Exchangeable suction-Irrigation tube - 04048223029527

Exchangeable suction-Irrigation tube M8 x 1, Ø 3mm, markings and 4 holes at distal end; Olympus-ID: A5799
Pajunk GmbH Medizintechnologie
1298-00-03OL
Not in Commercial Distribution

  • 04048223029527 ()
1298-00-03OL

  • Laparoscopic access cannula, reusable

ELMED - 00842180191426

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
ST13CG0823
In Commercial Distribution

  • 00842180191426 ()
ST13CG0823

  • Robotic surgical system application software

ELMED - 00842180182073

5mm, 45cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
52945-411
In Commercial Distribution

  • 00842180182073 ()
52945-411

  • Laparoscopic surgical procedure kit, non-medicated, reusable

Novo Surgical Inc. - 00842331181795

knolle-pearce irrigating lens loop, irrigating ports at 12, 10 & 2 o'clock, 23-gauge, 1 1/4" (3.0 cm)
NOVO SURGICAL, INC.
OP7123-66
In Commercial Distribution

  • 00842331181795 ()
OP7123-66

  • Surgical fluid/gas irrigator

ELMED - 00842180177390

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
13-CG0823
In Commercial Distribution

  • 00842180177390 ()
13-CG0823

  • Robotic surgical system application software

ELMED - 00842180175709

Frontal sinus probe, Double ended, angled hoot at one tip, 1.2 & 2 mm 8-1/2” (22 cm)
ELMED INCORPORATED
36382-41
In Commercial Distribution

  • 00842180175709 ()
36382-41

  • Surgical soft-tissue manipulation forceps, alligator, reusable

ELMED - 00842180199606

"Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 6-1/2in (16.5cm), M= PARTIALLY CLOSED TIP"
ELMED INCORPORATED
36-9153M
In Commercial Distribution

  • 00842180199606 ()
36-9153M

  • ENT surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506073694

10mm, 32cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST52932404JC
In Commercial Distribution

  • 00198506073694 ()
ST52932404JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506072703

3mm, 32cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST53932411JC
In Commercial Distribution

  • 00198506072703 ()
ST53932411JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable

ELMED - 00198506072680

5mm, 45cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST52945411JC
In Commercial Distribution

  • 00198506072680 ()
ST52945411JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506072697

3mm, 45cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST53945411JC
In Commercial Distribution

  • 00198506072697 ()
ST53945411JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506072673

5mm, 32cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
ST52932411JC
In Commercial Distribution

  • 00198506072673 ()
ST52932411JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506074653

Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 4-1/2in (11.4cm). M= PARTIALLY CLOSED TIP
ELMED INCORPORATED
36-9152M
In Commercial Distribution

  • 00198506074653 ()
36-9152M

  • ENT surgical procedure kit, non-medicated, reusable

ELMED INCORPORATED - 00198506074646

Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 4-1/2in (11.4cm). M= PARTIALLY CLOSED TIP
ELMED INCORPORATED
36-9151M
In Commercial Distribution

  • 00198506074646 ()
36-9151M

  • ENT surgical procedure kit, non-medicated, reusable

RZ Medizintechnik GmbH - 04049197454193

GOLDSTEIN Glenoid Neck Retractor 18 mm wide tip at teeth, 21.5 cm, 8 1/2" overall length
RZ-Medizintechnik GmbH
259-258-400
In Commercial Distribution

  • 04049197454193 ()
259-258-400

  • Hand-held surgical retractor, reusable

ASSI - 00841645124665

Breast Retractor w/Suction 4cm blade w/teeth at 90 degree angle, 4.0mm suction tube 12 FR
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ABR55626
In Commercial Distribution

  • 00841645124665 ()


  • Hand-held surgical retractor, reusable

Novo Surgical Inc. - 00842331149832

kleegman dilator, double-ended, stainless steel, 1.8 mm to 2.5 mm at tips, 10 3/4" (27.0 cm)
NOVO SURGICAL, INC.
OB6348-14
In Commercial Distribution

  • 00842331149832 ()
OB6348-14

  • Vaginal dilator
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