FDA.reportPublic FDA data

Double-Ended Probe, 19.5cm TL

Primary DI
00810009460947
Brand
Double-Ended Probe, 19.5cm TL
Company
MIZUHO AMERICA, INC.
Model
07-181-12MA
Device description
Probe
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810009460947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810009460947008100094609478100094609470810009460947

GMDN Terms#

Term, Definition table
TermDefinition
ENT probe, reusableA slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
877624940
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00810009460213Micro Dilator Forceps, Bayonet, Straight Tip, 35mm WL07-868-07MA2025-12-09
00810009466604Micro Dilator Forceps, Bayonet, Straight Tip, 50mm WL07-868-08MA2025-12-09
00810009465331Cottle Speculum, 110mm flared tip 99-200-092023-01-23
00810009465348Papevero Speculum 70mm 99-200-172023-01-23
00810009465355Trapezoidal Speculum 80mm down 99-200-182023-01-23
00810009465362Multi-hole atraumatic suction 9fr99-400-212022-12-05
00810009465393Osteotome, 8mm Tip, 6.5cm WL99-400-432022-12-02
00810009465416Periosteal Elevator, Straight, 12mm Tip, 7.5cm WL99-400-452022-12-02
00810009465492Tenotomy Scissors, Straight Jaw, Ring Handle, Thin Blades, 11cm99-600-332022-11-17
00810009460060Ring Curette, Donut Style, 3mm, Offset, 15cm WL10198MA2023-08-15
00810009460152LawtonElite Microscissors Bayonet, Reposable, Curved Right Blades, 10cm WL10294MA2023-08-15
00810009460169LawtonElite Microscissors Bayonet, Reposable, Curved Left Blades, 10cm WL10295MA2023-08-15
00810009460541Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL02-082-452023-08-15
00810009460824Yasargil Forceps, Bayonet, 11.5cm WL07-110-102023-08-15
00810009461180Ring Curette, Donut Style, 3mm, 125 Degrees Up, 15cm WL10296MA2023-08-15
00810009462132Sizer Dissector, Straight07-823-012023-08-15
00810009463054Rotatable Biopsy Forceps, 2mm Spoon, 12cm WL07-829-112023-08-15
00810009463580Sugita AVM Clip Case07-932-002023-08-15
00810009463801Biopsy Forceps, 1mm Spoon, 10cm WL07-869-022023-08-15

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