FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD84850
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD8485
Catalog number
SD8485
Device description
Bipolar Submucosal Turbinate Surgery System
Published
2020-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWAUnit, Electrosurgical And Coagulation, With Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWAUnit, Electrosurgical And Coagulation, With AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD84850PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089473ELMED INCORPORATEDELMED INCORPORATEDBWA2026-04-02
00198506088889ELMED INCORPORATEDELMED INCORPORATEDBWA2026-03-03
00198506084294ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-29
00198506053887ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-24
00198506054242ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-17
00198506053955ELMED INCORPORATEDELMED INCORPORATEDBWA2025-05-09
00198506064494ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506064883ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506061875ELMED INCORPORATEDELMED INCORPORATEDBWA2024-09-25
00198506060717ELMED INCORPORATEDELMED INCORPORATEDBWA2024-08-26
00842180175884ELMEDELMED INCORPORATEDBWA2023-08-11
00842180152908ELMEDELMED INCORPORATEDBWA2023-01-10
00842180156760ELMEDELMED INCORPORATEDBWA2023-01-09
10884521766662ValleylabCovidien LPBWA2021-04-08
00842180137004ELMEDELMED INCORPORATEDBWA2020-08-18
00842180136915ELMEDELMED INCORPORATEDBWA2020-06-17
00842180136724ELMEDELMED INCORPORATEDBWA2020-03-05
00842180136519ELMEDELMED INCORPORATEDBWA2019-11-06
00842180136472ELMEDELMED INCORPORATEDBWA2019-10-23
00842180135888ELMEDELMED INCORPORATEDBWA2019-04-09
00842180135833ELMEDELMED INCORPORATEDBWA2019-03-06
00842180135208ELMEDELMED INCORPORATEDBWA2018-10-01
00842180135178ELMEDELMED INCORPORATEDBWA2018-08-17
00842180111974ELMEDELMED INCORPORATEDBWA2018-03-07
00842180107946ELMEDELMED INCORPORATEDBWA2017-04-25
00842180106796ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106802ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106192ELMEDELMED INCORPORATEDBWA2016-10-25
00842180106208ELMEDELMED INCORPORATEDBWA2016-10-25
00842180106215ELMEDELMED INCORPORATEDBWA2016-10-25