FDA.reportPublic FDA data

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
B382SD309390Surgical DirectSD30939SD309392026-10-20
B382SD4810110Surgical DirectSD48-1011SD48-10112026-10-20
B382SD62362020Surgical DirectSD62362-02SD62362-022026-10-20
B382SD907310070Surgical DirectSD90731007SD907310072026-10-20
B382SD915070010Surgical DirectSD91507001SD915070012026-10-20
B382SD915070020Surgical DirectSD91507002SD915070022026-10-20
B382SD915070030Surgical DirectSD91507003SD915070032026-10-20
B382SD915758300Surgical DirectSD91575830SD915758302026-10-20
B382SD917665100Surgical DirectSD91766510SD917665102026-10-20
B382SD917665110Surgical DirectSD91766511SD917665112026-10-20
B382SD917665120Surgical DirectSD91766512SD917665122026-10-20
B382SD917665700Surgical DirectSD91766570SD917665702026-10-20
B382SD917665920Surgical DirectSD91766592SD917665922026-10-20
B382SD917665930Surgical DirectSD91766593SD917665932026-10-20
B382SD9210921080Surgical DirectSD921092108SD9210921082026-10-20
B382SD922624103T0Surgical DirectSD922624103TSD922624103T2026-10-20
B382SD9228132200Surgical DirectSD922813220SD9228132202026-10-20
B382SD9228132210Surgical DirectSD922813221SD9228132212026-10-20
B382SD9228132220Surgical DirectSD922813222SD9228132222026-10-20
B382SD9228132300Surgical DirectSD922813230SD9228132302026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD62371520Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903223060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454040Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD9030741020Surgical DirectSurgical Direct, Inc.EGN2026-10-08
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103062TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103107TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103113TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103116TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103118TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30