FDA.report

Surgical Direct

Primary DI
B382SD920062400
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92006240
Catalog number
SD92006240
Device description
Farrior Ear Speculum, 4.0mm x 5.0mm, Size 2
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SD920062400PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382S3797050Surgical DirectSurgical Direct, Inc.EGN2026-03-09
B382S9038721000Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD9038721050Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD90390415L0Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD92011811070Surgical DirectSurgical Direct, Inc.EGN2026-03-02
G1493803706TBS DentalACME ENTERPRISE.EGN2026-03-02
G1493806507TBS DentalACME ENTERPRISE.EGN2026-03-02
B382S3488110Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD903220230Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD9032161010Surgical DirectSurgical Direct, Inc.EGN2026-02-20
B382SD9035171020Surgical DirectSurgical Direct, Inc.EGN2026-02-16
B382SD9036541000Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398411L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
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B382S37921050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382S37921060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD59240Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720800Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720820Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6780830Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD80840Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9035401000Surgical DirectSurgical Direct, Inc.EGN2026-02-03
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B382SD90390214LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90391117LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095200Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095230Surgical DirectSurgical Direct, Inc.EGN2026-02-03
D9283001200SCISSORS METZ 5 3/4" CRV DELICATE TCW.H. Holden, Inc.EGN2026-01-06