FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD920060530
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92006053
Catalog number
SD92006053
Device description
Farrior Ear Speculum, 5.3mm Round
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD920060530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
08961104625839MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625846MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625907MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625914MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625921MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625938MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625952MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625969MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625976MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625983MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625990MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626003MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626010MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626027MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626034MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626041MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626058MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626096MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626102MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626119MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626126MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626133MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626140MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22