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
B382SD482012L0Surgical DirectSD48-2012LSD48-2012L2025-10-06
B382SD23170Surgical DirectSD2317SD23172026-10-15
B382SD25090Surgical DirectSD2509SD25092026-10-15
B382SD379410Surgical DirectSD37941SD379412026-10-15
B382SD4830070Surgical DirectSD48-3007SD48-30072026-10-15
B382SD4840320Surgical DirectSD48-4032SD48-40322026-10-15
B382SD48800050Surgical DirectSD48-80005SD48-800052026-10-15
B382SD491118030Surgical DirectSD49-111803SD49-1118032026-08-04
B382SD62371520Surgical DirectSD62-37152SD62-371522026-10-15
B382SD717510050Surgical DirectSD7175-1005SD7175-10052026-10-15
B382SD9025151020Surgical DirectSD902515102SD9025151022026-10-15
B382SD903223060Surgical DirectSD90322306SD903223062026-10-15
B382SD903454040Surgical DirectSD90345404SD903454042026-10-15
B382SD903454060Surgical DirectSD90345406SD903454062026-10-15
B382SD911434070Surgical DirectSD91143407SD911434072026-10-15
B382SD914174550Surgical DirectSD91417455SD914174552026-10-15
B382SD9141781090Surgical DirectSD914178109SD9141781092026-10-15
B382SD9141781620Surgical DirectSD914178162SD9141781622026-10-15
B382SD914603200Surgical DirectSD91460320SD914603202026-10-15
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432485MillenniumAvalign Technologies, Inc.FHL2026-09-28
00190776432492MillenniumAvalign Technologies, Inc.FHL2026-09-28
00190776432508MillenniumAvalign Technologies, Inc.FHL2026-09-28
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
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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