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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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SAFEDRAW(TM) DT-4812SDT - 00886333621422

A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682142
In Commercial Distribution

  • 50886333621427 ()
  • 00886333621422 ()

  • 3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc
682142

  • Invasive-pressure external transducer, single-use

NA - 30858512007052

Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and 2 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-12
In Commercial Distribution

  • 30858512007052 ()

  • Total Volume: 30 Milliliter
303-12

  • Multiple urine analyte IVD, control

ERA® Implant Abutment Micro 0°, 4mm Cuff (AT) - 00841549103513

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812396
In Commercial Distribution

  • 00841549103513 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 5mm Cuff (AT) - 00841549103520

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812397
In Commercial Distribution

  • 00841549103520 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 3mm Cuff (AT) - 00841549103506

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812395
In Commercial Distribution

  • 00841549103506 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 2mm Cuff (AT) - 00841549103490

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812394
In Commercial Distribution

  • 00841549103490 ()


  • Dental implant suprastructure, permanent, preformed

ERA® Implant Abutment Micro 0°, 1mm Cuff (AT) - 00841549103483

ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812393
In Commercial Distribution

  • 00841549103483 ()


  • Dental implant suprastructure, permanent, preformed

New Fine Arts - Adults at Play - Silicone 2 oz - 00796494002971

Silicone-Based Personal Lubricant
CC Wellness LLC
72224
In Commercial Distribution

  • 10796494002978 ()
  • 00796494002971 ()


  • Sexual lubricant

New Fine Arts - Adults at Play - Hybrid 2 oz - 00796494002964

Hybrid Personal Lubricant
CC Wellness LLC
72222
In Commercial Distribution

  • 10796494002961 ()
  • 00796494002964 ()


  • Sexual lubricant

New Fine Arts - Adults at Play - Agape 2 oz - 00796494002957

Water-based Personal Lubricant
CC Wellness LLC
72221
In Commercial Distribution

  • 10796494002954 ()
  • 00796494002957 ()


  • Sexual lubricant

A. Titan Instruments - 00841685101107

Osteotome, angled, convex, 4.5 mm < 5.0 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.06
In Commercial Distribution

  • 00841685101107 ()


  • Dental osteotome

A. Titan Instruments - 00841685101039

Osteotome, straight, convex, 4.0 mm < 4.5 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.05
In Commercial Distribution

  • 00841685101039 ()


  • Dental osteotome

A. Titan Instruments - 00841685100971

Osteotome, offset, concave, 4.0 mm < 4.5 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.05
In Commercial Distribution

  • 00841685100971 ()


  • Dental osteotome

A. Titan Instruments - 00841685100964

Osteotome, offset, concave, 3.5 mm < 4.0 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.04
In Commercial Distribution

  • 00841685100964 ()


  • Dental osteotome

Novo Surgical Inc. - 00842331142307

novo meniscus clamp, curved shank, 1x2 teeth at jaw tip, 7 1/4" (18.4 cm)
NOVO SURGICAL, INC.
N4632-32
In Commercial Distribution

  • 00842331142307 ()
N4632-32

  • Open-surgery biopsy forceps, reusable

Novo Surgical Inc. - 00842331138881

blumenthal rongeur, 4.0 mm wide jaws, 6 1/4" (16.0 cm), beak at 30-degree angle
NOVO SURGICAL, INC.
N4136-41
In Commercial Distribution

  • 00842331138881 ()
N4136-41

  • Craniofacial rongeur, reusable

Novo Surgical Inc. - 00842331131240

young renal pedicle clamp, curved, longitudinal serrations w/ cross serrations at tip, 9" (22.9 cm)
NOVO SURGICAL, INC.
G6268-94
In Commercial Distribution

  • 00842331131240 ()
G6268-94

  • Open-surgery biopsy forceps, reusable

Novo Surgical - 00842331117732

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-3/4" (4.5 cm)
NOVO SURGICAL, INC.
5561-47
Not in Commercial Distribution

  • 00842331117732 ()

  • Length: 26 Centimeter
5561-47

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

Novo Surgical - 00842331117725

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/2" (3.8 cm)
NOVO SURGICAL, INC.
5561-46
Not in Commercial Distribution

  • 00842331117725 ()

  • Length: 26 Centimeter
5561-46

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

Novo Surgical - 00842331117718

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/4" (3.2 cm)
NOVO SURGICAL, INC.
5561-45
Not in Commercial Distribution

  • 00842331117718 ()

  • Length: 26 Centimeter
5561-45

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

Novo Surgical - 00842331117701

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/8" (2.8 cm)
NOVO SURGICAL, INC.
5561-44
Not in Commercial Distribution

  • 00842331117701 ()

  • Length: 26 Centimeter
5561-44

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

Novo Surgical - 00842331125218

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-3/4" (4.5 cm)
NOVO SURGICAL, INC.
C6672-58
In Commercial Distribution

  • 00842331125218 ()

  • Length: 4.5 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125201

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/2" (3.8 cm)
NOVO SURGICAL, INC.
C6672-57
In Commercial Distribution

  • 00842331125201 ()

  • Length: 3.8 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125195

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/4" (3.2 cm)
NOVO SURGICAL, INC.
C6672-56
In Commercial Distribution

  • 00842331125195 ()

  • Length: 3.2 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125188

Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/8" (2.8 cm)
NOVO SURGICAL, INC.
C6672-55
In Commercial Distribution

  • 00842331125188 ()

  • Length: 2.8 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical Inc. - 00842331147562

blumenthal rongeur, 4.0 mm wide jaws, 6 1/4" (16.0 cm), beak at 45-degree angle
NOVO SURGICAL, INC.
N4136-56
In Commercial Distribution

  • 00842331147562 ()
N4136-56

  • Craniofacial rongeur, reusable

Pick Pack - 00310866002484

Tweezers with the characteristic head of the R-101 packing instrument are incorporated at the tip.
PASCAL COMPANY, INC.
26210
In Commercial Distribution

  • 00310866002484 ()
26210

  • Gingival retraction cord packing tool

ELMED - 00198506057007

MENISCUS CLAMP WITH CURVED SHANK, 1 X 2 TEETH AT TIP OF JAWS, STAINLESS STEEL
ELMED INCORPORATED
23-5274OS
In Commercial Distribution

  • 00198506057007 ()
23-5274OS

  • Arthroscopic surgical procedure kit, non-medicated, reusable

MSI Precision Specialty Instruments - 00194613060893

Chandler Elevator Blunt 17mm Width At Tip 25mm Maximum Width With Overall Length 9" (229mm)
Med Saver, Inc.
D6254
In Commercial Distribution

  • 00194613060893 ()


  • Bone lever/elevator, reusable

MSI Precision Specialty Instruments - 00194613097196

Brierley Capsularhexis Cannula 21g Tapering to 26g at Tip. 0.25mm Aspirating Port on Posterior Surface
Med Saver, Inc.
11-8-5606
In Commercial Distribution

  • 00194613097196 ()


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

microTargeting™ Insertion Tube - 00873263003275

microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexframe and Nexdrive
FHC, INC.
66-IT-DB12P-00327
In Commercial Distribution

  • 10873263003272 ()
  • 00873263003275 ()

  • Length: 211.6 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
66-IT-DB12P

  • Intracerebral cannula, implantable

Proov - 00860002790817

Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit

Proov - 00850035206126

At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.
Mfb Fertility, Inc.
Pregnancy Pack
In Commercial Distribution

  • 00850035206126 ()


  • Natural conception assistance kit

Surgical Direct - B382SD9147461020

7 1/8 inch Meniscus Clamp, Curved Shanks, 1 X 2 Teeth At Jaw Tip
Surgical Direct, Inc.
SD914746102
In Commercial Distribution

  • B382SD9147461020 ()
SD914746102

  • Orthopaedic bone-fragment manipulator, reusable

Integra® Miltex® - 10381780418429

Integra® Miltex® McPherson Suture Tying Forceps 3-1/2", Angled, 0.33mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-949
In Commercial Distribution

  • H834189490 ()
  • 10381780418429 ()

  • 3-1/2"
  • Width: 0.35 Millimeter
18-949

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

Integra® Miltex® - 10381780418412

Integra® Miltex® McPherson Suture Tying Forceps 3-1/2", Straight, 0.33mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-948
In Commercial Distribution

  • H834189480 ()
  • 10381780418412 ()

  • Width: 0.35 Millimeter
  • 3-1/2"
18-948

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

Integra® Miltex® - 10381780417835

Integra® Miltex® Eye Dressing Forceps, 4", Standard, Straight, Serrated, 0.8mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-780
In Commercial Distribution

  • H834187800 ()
  • 10381780417835 ()

  • Width: 0.8 Millimeter
  • Length: 4 Inch
18-780

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

Surgical Direct - B382SD9206611010

7 1/2" Double Ended Rosen Cartilage Knife, Blades Set At 45 and 90 Degree
Surgical Direct, Inc.
SD920661101
In Commercial Distribution

  • B382SD9206611010 ()
SD920661101

  • Ear excavator

Integra® Miltex® - 10381780424710

Integra® Miltex® Friedman Oral Surgery Rongeur 5-5/8", Delicate, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-494
In Commercial Distribution

  • H834224940 ()
  • 10381780424710 ()
22-494

  • Dental rongeur

HELMUT ZEPF - EZPF50226160

PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. STRAIGHT, 16 CM, MOUTH WIDTHNESS 1,7 MM
Helmut Zepf Medizintechnik GmbH
50.226.16
In Commercial Distribution

  • EZPF50226160 ()
50.226.16

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

Integra® - 10381780082194

Integra® Saunders Paparella Window Rasp & Marker, Malleable Shaft Marked at 4, 4.5, & 5 mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3722107
In Commercial Distribution

  • 10381780082194 ()
3722107

  • Middle ear file/rasp

Diamatrix - 00813059013880

Toric IOL Reference Marker, Conical Micro-Teeth Positioned at 0, 90, and 180 Degrees, Stainless Steel
Diamatrix
M24400
In Commercial Distribution

  • 00813059013880 ()


  • Corneal marker, reusable

Accu-Beam - B17710597120

Re-usable fiberoptic handpiece for lasers. 190mm/163.1 with 35 degree bend. 30.7R at tip. Blue.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
1059712
In Commercial Distribution

  • B17710597120 ()


  • General/multiple surgical laser system beam guide, reusable

Integra® Miltex® - 10381780487395

Integra® Miltex® McPherson Suture Tying Forceps, 3-1/2", Angled, 0.3mm Wide At Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH18-949
In Commercial Distribution

  • H834MH189490 ()
  • 10381780487395 ()
MH18-949

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

Lead Slit Mittens - G031101SLMITRL0

Lead mittens - 15" one piece dip molded - w/ slit at base of fingers for dexterity
Shielding International Inc.
101SLMITRL
In Commercial Distribution

  • G031101SLMITRL0 ()


  • Radiation-shielding procedure preparation glove/mitten

Ambler Surgical - 00190660128074

Skillern sinus probe, 6 1/2'', graduated beads at 5cm, 7cm and 9cm, probe tip
AMBLER SURGICAL CORP.
Skillern sinus probe
In Commercial Distribution

  • 00190660128074 ()
44-660

  • Fistula probe

Hayden Medical - 00840319703984

DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 9-1/2" (24cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-524NC
In Commercial Distribution

  • 00840319703984 ()
120-524NC

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

Hayden Medical - 00840319703960

DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 7-3/4" (19.5cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-522NC
In Commercial Distribution

  • 00840319703960 ()
120-522NC

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

Hayden Medical - 00840319703939

DeBakey Atraumatic Tissue Forceps, 1.5mm wide tips, 9-1/2" (24cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-514NC
In Commercial Distribution

  • 00840319703939 ()
120-514NC

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

Hayden Medical - 00840319703915

DeBakey Atraumatic Tissue Forceps, 1.5mm wide tips, 7-3/4" (19.5cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-512NC
In Commercial Distribution

  • 00840319703915 ()
120-512NC

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