FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9115011000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD911501100
Catalog number
SD911501100
Device description
6 3/4" Coupland Suction Handle
Published
2026-09-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9115011000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10
B382SD9344181010Surgical DirectSD934418101SD9344181012026-07-10
B382SD9344181020Surgical DirectSD934418102SD9344181022026-07-10
B382SD9344181030Surgical DirectSD934418103SD9344181032026-07-10
B382SD921226190Surgical DirectSD92122619SD921226192022-12-01
B382SD070823101310Surgical DirectSD07082-31013-1SD07082-31013-12026-09-30
B382SD13768330Surgical DirectSD13768-33SD13768-332026-09-30
B382SD8160490Surgical DirectSD816049SD8160492026-09-30
B382SD90293310010Surgical DirectSD9029331001SD90293310012026-09-30
B382SD907620220Surgical DirectSD90762022SD907620222026-09-30
B382SD914800210Surgical DirectSD91480021SD914800212026-09-30
B382SD9156321100Surgical DirectSD915632110SD9156321102026-09-30
B382SD921329100Surgical DirectSD92132910SD921329102026-09-30
B382SD1455810020Surgical DirectSD14558-1002SD14558-10022026-09-29
B382SD1455810030Surgical DirectSD14558-1003SD14558-10032026-09-29
B382SD30550860Surgical DirectSD30550-86SD30550-862026-09-29
B382SD49195170Surgical DirectSD49195-17SD49195-172026-09-29
B382SD4937851340Surgical DirectSD49-3785-134SD49-3785-1342026-09-29
B382SD546210000Surgical DirectSD5462-1000SD5462-10002026-09-29
B382SD903260120Surgical DirectSD90326012SD903260122026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713787PRINCETONPrinceton Medical Group, Inc.JOL2026-09-22
00190776423803MillenniumAvalign Technologies, Inc.JOL2026-08-26
04250603753148LAZICPeter Lazic GmbHJOL2026-08-25
04250603753155LAZICPeter Lazic GmbHJOL2026-08-25
04250603753162LAZICPeter Lazic GmbHJOL2026-08-25
04250603753179LAZICPeter Lazic GmbHJOL2026-08-25
04250603753186LAZICPeter Lazic GmbHJOL2026-08-25
04250603753193LAZICPeter Lazic GmbHJOL2026-08-25
00190776408695MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776408725MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776422813MillenniumAvalign Technologies, Inc.JOL2026-08-03
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23