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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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Li-ion Battery charger - 04547410180220

A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital

.decimal Electron Aperture - 00851147007038

A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007038 ()


  • Radiation therapy beam block material

Baby Blue Pink - 00851478007059

This light therapy beauty tool attacks blemishes at its core without the need for oral medications
QUASAR BIO-TECH INC.
DPA-002-PK
In Commercial Distribution

  • 00851478007059 ()
DPA-002-PK

  • Blue/red/infrared phototherapy lamp

Baby Blue - 00851478007042

This light therapy beauty tool attacks blemishes at its core without the need for oral medications
QUASAR BIO-TECH INC.
DPA-002
In Commercial Distribution

  • 00851478007042 ()
DPA-002

  • Blue/red/infrared phototherapy lamp

Proov - 00850035206058

At home IVD FSH test to measure follicle stimulating hormone and check your ovarian reserve status.
Mfb Fertility, Inc.
Reserve
In Commercial Distribution

  • 00850035206058 ()


  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

HNM MEDICAL - 00842962161807

SIZE 2, 0 WT/B FORCEBRAID 20", UHMWPE NO, AB SURGICAL SUTURE W/AT, 2 NEEDLE
HNM STAINLESS, LLC.
HNM-VAL2020WBN
In Commercial Distribution

  • 00842962161807 ()
HNM-VAL2020WBN

  • Suturing unit, reusable

Novo Surgical - 00842331115776

Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), satinsky
NOVO SURGICAL, INC.
5550-03
Not in Commercial Distribution

  • 00842331115776 ()

  • Length: 14 Centimeter
5550-03

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Novo Surgical - 00842331123252

Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), satinsky
NOVO SURGICAL, INC.
C6661-14
In Commercial Distribution

  • 00842331123252 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp

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

Ambler Surgical - 00190660155933

Helveston scleral ruler, 6'', vaulted, notches in 5.0mm increments, single marking tooth at tip, flat handle
AMBLER SURGICAL CORP.
Helveston scleral ruler
In Commercial Distribution

  • 00190660155933 ()
1112E

  • General-purpose calliper, metallic

Ambler Surgical - 00190660185749

Peck suction tube, 7 1/2'', 4.0mm diameter, calibrated at 5cm, 6cm, 7cm, 8cm and 9cm
AMBLER SURGICAL CORP.
Peck suction tube
In Commercial Distribution

  • 00190660185749 ()
89-700

  • Surgical/emergency suction cannula, non-illuminating, 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

Integra® Miltex® - 10381780424871

Integra® Miltex® Mead Oral Surgery Rongeur 6-1/2", No. 1, Jaws at 45° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-432
In Commercial Distribution

  • H83422D4320 ()
  • 10381780424871 ()
22D-432

  • Dental rongeur

Integra® Miltex® - 10381780424697

Integra® Miltex® Cleveland Oral Surgery Rongeur 6-1/2", No. 4A, Jaws at 35° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-488
In Commercial Distribution

  • H834224880 ()
  • 10381780424697 ()
22-488

  • Dental rongeur

Integra® Miltex® - 10381780424680

Integra® Miltex® Cleveland Oral Surgery Rongeur 5-1/2", No. 4, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-486
In Commercial Distribution

  • H834224860 ()
  • 10381780424680 ()
22-486

  • Dental rongeur

Integra® Miltex® - 10381780424673

Integra® Miltex® Mead Oral Surgery Rongeur 6-1/2", No. 1A, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-484
In Commercial Distribution

  • H834224840 ()
  • 10381780424673 ()
22-484

  • Dental rongeur

Integra® Miltex® - 10381780418504

Integra® Miltex® Nugent Utility Forceps 4-3/8", Angled Jaws, Cross-Serrated, 1.2mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-958
In Commercial Distribution

  • H834189580 ()
  • 10381780418504 ()

  • Width: 1.2 Millimeter
  • 4-3/8"
18-958

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

Integra® Miltex® - 10381780417859

Integra® Miltex® Eye Dressing Forceps 4", Standard, Half Curved, Serrated, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-782
In Commercial Distribution

  • H834187820 ()
  • 10381780417859 ()
18-782

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

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

Integra® Jarit® - 10381780407874

Integra® Jarit® Mead Oral Surgery Rongeur 6-1/2", No. 1, Jaws at 45° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E543
In Commercial Distribution

  • M274X33E5431 ()
  • 10381780407874 ()
X33E543

  • Dental rongeur

Integra® Jarit® - 10381780407799

Integra® Jarit® Cleveland Oral Surgery Rongeur 6-1/2", No. 4A, Jaws at 35° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33599
In Commercial Distribution

  • M274X335991 ()
  • 10381780407799 ()
X33599

  • Dental rongeur

BodyMed - 00815991024191

BODYMED LED MOIST AND DRY HEATING PAD, WITH AUTO SHUT-OFF AT 2 HOURS. 12" X 15"
BOXOUT, LLC
ZZHP1215EA
In Commercial Distribution

  • 20815991024195 ()
  • 00815991024191 ()


  • External electric-heating core temperature regulation system pad

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

Integra® Jarit® - 10381780406167

Integra® Jarit® Strabismus Forceps 4", Straight, 1 x 2 Teeth, 1mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X29951
In Commercial Distribution

  • M274X299511 ()
  • 10381780406167 ()
X29951

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

ELMED - 00198506057540

Fansler proctoscope. Open at top. 1-1/3" (3.3cm) Diameter. Mirror finish. Working length 2-3/8in (6cm).
ELMED INCORPORATED
EL-SU220
In Commercial Distribution

  • 00198506057540 ()
EL-SU220

  • Optical anoscope, reusable

JOBST Elvarex - 04019702295290

Elvarex 2/Mid Thigh High/Profile-Slant-Open Toe/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77340-00070-00
In Commercial Distribution

  • 04019702295290 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702294972

Elvarex 2/Mid Thigh High/Slant-Open Toe-Elephantiasis-Version/Thigh high without volant to sew at body bandage
BSN-Jobst GmbH
77340-00092-00
In Commercial Distribution

  • 04019702294972 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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