FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD91143014A0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91143014A
Catalog number
SD91143014A
Device description
14fr Frazier Suction Tube Stylet
Published
2026-02-05
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
B382SD91143014A0PrimaryHIBCC0

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
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD48301400Surgical DirectSurgical Direct, Inc.KCB2026-03-09
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
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