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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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ID NOW Strep A 2 Control Swab Kit - 10811877010583

Control Swabs intended for use only with the ID NOW Strep A 2 product.
Alere Scarborough, Inc.
734-080
In Commercial Distribution

  • 10811877010583 ()


  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control

gSource - 00840314246318

Screwdriver 8 3/4" hex 3.5mm with notch, max ID 1.75mm cann, phen hdl
GSOURCE LLC
gS 86.4495
In Commercial Distribution

  • 00840314246318 ()
gS 86.4495

  • Surgical screwdriver, reusable

gSource - 00840314246288

Screwdriver 7 3/4" hex 2.5mm with notch, max ID 1.35mm cann, phen hdl
GSOURCE LLC
gS 86.4410
In Commercial Distribution

  • 00840314246288 ()
gS 86.4410

  • Surgical screwdriver, reusable

Coulmed - 10810087351189

Gel Adult Head Horseshoe Positioner, Size: 8"OD x 3"ID x 2"T
Coulmed Products Group LLC
GP204
In Commercial Distribution

  • 10810087351189 ()
GP204

  • Freestanding patient positioner, reusable

Coulmed - 10810087351158

Gel Adult Head Donut Positioner, Size: 8"OD x 3"ID x 2"T
Coulmed Products Group LLC
GP201
In Commercial Distribution

  • 10810087351158 ()
GP201

  • Freestanding patient positioner, reusable

Hayden Medical - 00840319707609

Chalazion Forceps 3-1/4" (8.9cm), oval 12mm x 14mm ID, hollow on both sides
Hayden Medical, Inc.
210-834
In Commercial Distribution

  • 00840319707609 ()
210-834

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

Hayden Medical - 00840319744673

Desmarres Chalazion Forceps 3-1/2" (8.8cm), medium, oval 12 x 23mm ID, Non Conductive
Hayden Medical, Inc.
210-192NC
In Commercial Distribution

  • 00840319744673 ()
210-192NC

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

Hayden Medical - 00840319722770

Fansler Operating Speculum, 1-3/8" (3.5 cm)ID, 2-3/8" (6.1 cm) Slotted Tube
Hayden Medical, Inc.
280-050
In Commercial Distribution

  • 00840319722770 ()
280-050

  • Rectal speculum

CANNULA Ø6.0MM L200MM - 03760244030733

Cannula Ø6mm/Ø2.50mm L200mm instrument Rosa one (spine application) Cannula OD 5.95mm ID 2.50mm
MEDTECH
ROSA3-157A
Not in Commercial Distribution

  • 03760244030733 ()
ROSAS00167

  • Multi-purpose stereotactic surgery system

Globe Scientific - 00840095608077

Tite-Rite Container, 90mL (3oz), with Attached White Screw Cap and ID Label, Graduated, STERILE
GLOBE SCIENTIFIC INC.
6220
In Commercial Distribution

  • 00840095608077 ()
  • 00840095611923 ()
  • 00840095608084 ()


  • General specimen container IVD, no additive, sterile

Resp-O2 Small Volume Nebulizer 6 cc Cup - 00840117311879

7' (2.1m) Tubing, Standard Connector with Spring Loaded T (22mm ID x 22mm OD)
Dynarex Corporation
34103
In Commercial Distribution

  • 00840117311886 ()
  • 00840117311879 ()


  • Nebulizing system delivery set, reusable

Bone Reduction Clamp - 00192896107540

Bone Reduction Clamp 12 Millimeters K-Wire 1.8 Millimeter ID Guide With Double Long Ratchet
SONTEC INSTRUMENTS, INC.
1103-0453
In Commercial Distribution

  • 00192896107540 ()

  • Length: 8 Inch


  • Bone approximation clamp

Ambler Surgical - 00190660192693

Replacement Silicone tubing, 12'', 0.030'' ID x 0.065'' OD x 0.018'' wall, with adaptor
AMBLER SURGICAL CORP.
Replacement Silicone tubing
In Commercial Distribution

  • 00190660192693 ()
1212E

  • Ophthalmic irrigation/infusion/aspiration tubing, reusable

QUASAR - G34350036060200

MRI4D - 20mm ID fillable hollow sphere tumour model, thread adapter and universal stem pkg
Modus Medical Devices Inc
500-3606-020
In Commercial Distribution

  • G34350036060200 ()


  • Multi-modality therapeutic radiation phantom, test object

PEAK MED - G4533324040504

AORTA / AORTIC - COMPRESSOR / OCCLUDER W/ 1/2" OD X 1/4" ID SILICONE TUBING
Peak Medical Distribution Inc.
3324-0405
In Commercial Distribution

  • G4533324040504 ()


  • Surgical retractor/retraction system blade, reusable

V. Mueller - 10885403314414

GENESIS BASKET ID TAG EXTRA-LARGE, BLUE 1 X 3 inches 2.5 X 7.6 CM
STERIS CORPORATION
TB3-2
In Commercial Distribution

  • 10885403314414 ()
TB32

  • Device operating status label/tag, reusable

VERTEBRIS - 04055207068380

WORKING SLEEVE ID 13.6MM OD 14.6MM TL 145mm, Distal end with double window, reusable
Richard Wolf GmbH
892209013
In Commercial Distribution

  • 04055207068380 ()

  • Length: 145 Millimeter
  • Lumen/Inner Diameter: 13.6 Millimeter
  • Outer Diameter: 14.6 Millimeter
892209013

  • Endoscope sheath, reusable

VERTEBRIS - 04055207068373

WORKING SLEEVE ID 14.5MM OD 15.5MM TL 145mm, Distal end with double window, reusable
Richard Wolf GmbH
892209012
In Commercial Distribution

  • 04055207068373 ()

  • Outer Diameter: 15.5 Millimeter
  • Length: 145 Millimeter
  • Lumen/Inner Diameter: 14.5 Millimeter
892209012

  • Endoscope sheath, reusable

VERTEBRIS - 04055207065716

WORKING SLEEVE ID 7MM OD 8MM TL 166 mm, distal end beveled, graduated, reusable
Richard Wolf GmbH
15208262
In Commercial Distribution

  • 04055207065716 ()

  • Length: 166 Millimeter
  • Outer Diameter: 8 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
15208.262

  • Endoscope sheath, reusable

VERTEBRIS - 04055207065709

WORKING SLEEVE ID 6MM OD 7MM TL 166 mm, distal end straight, graduated, reusable
Richard Wolf GmbH
15208261
Not in Commercial Distribution

  • 04055207065709 ()

  • Length: 166 Millimeter
  • Outer Diameter: 7 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
15208.261

  • Endoscope sheath, reusable

OMNI Interface Acetabular System - 00841690120391

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, F Insert, 40mm ID
Omni Life Science, Inc.
H6-15240
In Commercial Distribution

  • 00841690120391 ()
H6-15240

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120353

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, E Insert, 40mm ID
Omni Life Science, Inc.
H6-14840
In Commercial Distribution

  • 00841690120353 ()
H6-14840

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120346

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, E Insert, 36mm ID
Omni Life Science, Inc.
H6-14836
In Commercial Distribution

  • 00841690120346 ()
H6-14836

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120315

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, D Insert, 36mm ID
Omni Life Science, Inc.
H6-14436
In Commercial Distribution

  • 00841690120315 ()
H6-14436

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120285

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, C Insert, 32mm ID
Omni Life Science, Inc.
H6-14132
In Commercial Distribution

  • 00841690120285 ()
H6-14132

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120261

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, B Insert, 28mm ID
Omni Life Science, Inc.
H6-13928
In Commercial Distribution

  • 00841690120261 ()
H6-13928

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120254

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 0 degree Hood +4mm Offset, A Insert, 28mm ID
Omni Life Science, Inc.
H6-13728
In Commercial Distribution

  • 00841690120254 ()
H6-13728

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120247

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 10 degree Hood +4mm Offset, F Insert, 36mm ID
Omni Life Science, Inc.
H6-05236
In Commercial Distribution

  • 00841690120247 ()
H6-05236

  • Non-constrained polyethylene acetabular liner

OMNI Interface Acetabular System - 00841690120230

ApeX-LNK Crosslinked Acetabular Insert, UHMWPE 10 degree Hood +4mm Offset, F Insert, 40mm ID
Omni Life Science, Inc.
H6-05240
In Commercial Distribution

  • 00841690120230 ()
H6-05240

  • Non-constrained polyethylene acetabular liner
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