FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD48301400
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD48-30140
Catalog number
SD48-30140
Device description
5mm 40cm Ball Tipped Endoscopy Suction Tube, 45 Degree Bend
Published
2026-03-09
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
KCBTUBE, TONSIL SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD48301400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD883110450Surgical DirectSD88311045SD883110452026-07-10
B382SD88324450Surgical DirectSD8832445SD88324452026-07-10
B382SD9032161000Surgical DirectSD903216100SD9032161002026-07-10
B382SD90390213SC0Surgical DirectSD90390213SCSD90390213SC2026-07-10
B382SD9044561000Surgical DirectSD904456100SD9044561002026-07-10
B382SD92268003T0Surgical DirectSD92268003TSD92268003T2026-07-10
B382SD92268030T0Surgical DirectSD92268030TSD92268030T2026-07-10
B382SD92268031T0Surgical DirectSD92268031TSD92268031T2026-07-10
B382SD92268032T0Surgical DirectSD92268032TSD92268032T2026-07-10
B382SD92268033T0Surgical DirectSD92268033TSD92268033T2026-07-10
B382SD92268034T0Surgical DirectSD92268034TSD92268034T2026-07-10
B382SD92268035T0Surgical DirectSD92268035TSD92268035T2026-07-10
B382SD92268036T0Surgical DirectSD92268036TSD92268036T2026-07-10
B382SD92268037T0Surgical DirectSD92268037TSD92268037T2026-07-10
B382SD92268038T0Surgical DirectSD92268038TSD92268038T2026-07-10
B382SD92268039T0Surgical DirectSD92268039TSD92268039T2026-07-10
B382SD92268040T0Surgical DirectSD92268040TSD92268040T2026-07-10
B382SD92268041T0Surgical DirectSD92268041TSD92268041T2026-07-10
B382SD92268042T0Surgical DirectSD92268042TSD92268042T2026-07-10
B382SD92268043T0Surgical DirectSD92268043TSD92268043T2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD911451080Surgical DirectSurgical Direct, Inc.KCB2026-03-02
B382SD6770650Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9194441080Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD920223100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9204111140Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9227771100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD4930130450Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD61042070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD6786020Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430081A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD91143014A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911431107A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511180Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511490Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511500Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511680Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860310Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860320Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860330Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860340Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430150Surgical DirectSurgical Direct, Inc.KCB2025-12-02
B382SD471400820Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114311000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114312000Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD9114511830Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911451185A0Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911500010Surgical DirectSurgical Direct, Inc.KCB2025-11-05
B382SD911500020Surgical DirectSurgical Direct, Inc.KCB2025-11-05