FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9162111090
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD916211109
Catalog number
SD916211109
Device description
9" Berens Common Duct Scoop, Small
Published
2026-07-28
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
FHLScoop

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9162111090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological scoopA heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. The device is typically made of high-grade stainless steel and has a malleable (bendable) distal tip to assist with accessibility to the various sites; it has a handle at the proximal end. The scoop is available in various shapes and sizes. 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
B382S2752108T0Surgical DirectS2752.108TS2752.108T2026-08-03
B382SD20260Surgical DirectSD2-026SD2-0262026-08-03
B382SD319590Surgical DirectSD31959SD319592026-08-03
B382SD32153690Surgical DirectSD3215369SD32153692026-08-03
B382SD346130Surgical DirectSD34613SD346132026-08-03
B382SD350110Surgical DirectSD914709148SD9147091482026-08-03
B382SD38060Surgical DirectSD3806SD38062026-08-03
B382SD4121490Surgical DirectSD412149SD4121492026-08-03
B382SD4131490Surgical DirectSD413149SD4131492026-08-03
B382SD4162910Surgical DirectSD416291SD4162912026-08-03
B382SD4319D0Surgical DirectSD4319DSD4319D2026-08-03
B382SD439190Surgical DirectSD43919SD439192026-08-03
B382SD441309197120Surgical DirectSD4413-0919712SD4413-09197122026-08-03
B382SD45267180Surgical DirectSD45-26718SD45-267182026-08-03
B382SD459000Surgical DirectSD45900SD459002026-08-03
B382SD460350Surgical DirectSD46035SD460352026-08-03
B382SD460360Surgical DirectSD46036SD460362026-08-03
B382SD467000Surgical DirectSD46700SD467002026-08-03
B382SD467010Surgical DirectSD46701SD467012026-08-03
B382SD467020Surgical DirectSD46702SD467022026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422943MillenniumAvalign Technologies, Inc.FHL2026-08-03
00190776422950MillenniumAvalign Technologies, Inc.FHL2026-08-03
00190776422967MillenniumAvalign Technologies, Inc.FHL2026-08-03
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
00887482173695Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174708Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174715Symmetry FergusonASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174777Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174784Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174791Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00887482174807Symmetry DesjardinsASPEN SURGICAL PRODUCTS, INC.FHL2024-08-15
00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
00810158210158PRINCETONPrinceton Medical Group, Inc.FHL2024-03-05
G586UR96223150Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225100Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225170Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225180Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96225190Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226120Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226130Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18
G586UR96226140Novo SurgicalNOVO SURGICAL, INC.FHL2023-12-18