Surgical Direct

Primary DI
B382SD9200650500
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD920065050
Catalog number
SD920065050
Device description
Farrior Ear Speculum, 5mm x 6mm Oval, Oblique
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B382SD9200650500PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382S8711000Surgical DirectS871.100S871.1002026-07-14
B382S8711010Surgical DirectS871.101S871.1012026-07-14
B382S8711020Surgical DirectS871.102S871.1022026-07-14
B382SD08890310101D0Surgical DirectSD08890-31010-1DSD08890-31010-1D2026-07-14
B382SD08890320101D0Surgical DirectSD08890-32010-1DSD08890-32010-1D2026-07-14
B382SD1184590Surgical DirectSD118459SD1184592026-07-14
B382SD123750Surgical DirectSD12375SD123752026-07-14
B382SD123760Surgical DirectSD12376SD123762026-07-14
B382SD123780Surgical DirectSD12378SD123782026-07-14
B382SD124326191140Surgical DirectSD12432-619-114SD12432-619-1142026-07-14
B382SD12711090Surgical DirectSD1271-109SD1271-1092026-07-14
B382SD1271390Surgical DirectSD1271-39SD1271-392026-07-14
B382SD1271590Surgical DirectSD1271-59SD1271-592026-07-14
B382SD13018770Surgical DirectSD13018-77SD13018-772026-07-14
B382SD13024290Surgical DirectSD1302.429SD1302.4292026-07-14
B382SD13168350Surgical DirectSD13168-35SD13168-352026-07-14
B382SD209910FSANT0Surgical DirectSD209910-FS-AN-TSD209910-FS-AN-T2026-07-14
B382SD209920FSANT0Surgical DirectSD209920-FS-AN-TSD209920-FS-AN-T2026-07-14
B382SD209923FSANT0Surgical DirectSD209923-FS-AN-TSD209923-FS-AN-T2026-07-14
B382SD2303290Surgical DirectSD230329SD2303292026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD903988102SC0Surgical DirectSurgical Direct, Inc.EGN2026-07-14
B382SD9039991090Surgical DirectSurgical Direct, Inc.EGN2026-07-14
00841013124716MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.EGN2026-06-26
B382S37841020Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37842000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37935000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903070100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903071100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD90315118T0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9034541060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035521000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035651000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037861000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037871010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903797030Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903870060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039790010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039871000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
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