FDA.reportPublic FDA data

Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps

Primary DI
00810024670260
Brand
Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps
Company
CENTERPOINT SYSTEMS LLC
Model
DFE-MD-000652
Device description
Single use pancreaticobiliary scope
Published
2024-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope And Accessories, Flexible/Rigid
NTNLed Light Source
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2
NTNLed Light SourceGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233752000Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsCenterPoint Systems, LLC2024-05-02FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024670260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024670260008100246702608100246702600810024670260

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video choledochoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. It is typically introduced via a flexible duodenoscope and anatomical images are transmitted to a monitor for viewing typically through a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117126091
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024671885CPS Locator 3D, Small Delivery CatheterDS2C100-42DS2C100-422026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterDS2C200-422026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterDS2C300-42DS2C300-422026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterDS2C200-45DS2C200-452026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterDS2C300-45DS2C300-452026-07-13
00810024671953SSPC NXT Delivery Catheter92932026-06-01
00810024672134CPS Locator 3D, BB1-36DS2CBB1-36DS2CBB1-362026-03-30
00810024672141CPS Locator 3D, BB1-40DS2CBB1-40DS2CBB1-402026-03-30
00810024671991AuST Steerable Sheath0-132H-H3574SAN0-SNSP02026-01-29
00810024672004AuST Steerable Sheath0-132H-H5074SAN0-SNSP02026-01-29
00810024670314AuST Steerable Sheath0-120H-H1774SAN5-SNSP02026-01-12
00810024670536AuST Steerable Sheath0-085H-H1774SAN0-SNSP02026-01-12
00810024670543AuST Steerable Sheath0-085H-H2274SAN0-SNSP02026-01-12
00810024670550AuST Steerable Sheath0-085H-H5074SAN0-SNSP02026-01-12
00810024671724DF4 Helix Locking ToolA002HELX2025-12-03
00810024671342AuST Steerable Sheath0-085H-H1744SAN0-SNSP02025-11-05
00810024671359AuST Steerable Sheath0-085H-H2244SAN0-SNSP02025-11-05
00810024671366AuST Steerable Sheath0-085H-H3544SAN0-SNSP02025-11-05
00810024671373AuST Steerable Sheath0-085H-H5044SAN0-SNSP02025-11-05
00810024671380AuST Steerable Sheath0-132H-H3544SAN0-SNSP02025-11-05

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Primary DI, Brand, Company table
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04055207007709NARichard Wolf GmbHFBN2026-05-29
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04055207007747NARichard Wolf GmbHFBN2026-05-29
04055207007792NARichard Wolf GmbHFBN2026-05-29
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