FDA.reportPublic FDA data

MultiStage®

Primary DI
06934184004124
Brand
MultiStage®
Company
Dongguan TT Medical, Inc.
Model
MSO-1030-08
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222663000MultiStage Balloon Dilatation CatheterDongguan TT Medical, Inc.2023-03-09FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934184004124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934184004124069341840041246934184004124

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheter, non-medicatedA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551476865
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934184004100MultiStage®MSO-0630-082025-02-10
06934184004117MultiStage®MSW-0830-082025-02-10
06934184004131MultiStage®MSO-1230-082025-02-10
06934184004148MultiStage®MSO-1530-082025-02-10
06934184004155MultiStage®MSO-1830-082025-02-10
06934184004162MultiStage®MSO-0630-172025-02-10
06934184004179MultiStage®MSO-0830-172025-02-10
06934184004186MultiStage®MSO-1030-172025-02-10
06934184004193MultiStage®MSO-1230-172025-02-10
06934184004209MultiStage®MSO-1530-172025-02-10
06934184004216MultiStage®MSO-1830-172025-02-10
06934184004223MultiStage®MSO-0630-232025-02-10
06934184004230MultiStage®MSO-0830-232025-02-10
06934184004254MultiStage®MSO-1230-232025-02-10
06934184004261MultiStage®MSO-1530-232025-02-10
06934184004278MultiStage®MSO-1830-232025-02-10
06934184004285MultiStage®MSO-0655-082025-02-10
06934184004292MultiStage®MSO-0855-082025-02-10
06934184004308MultiStage®MSO-1055-082025-02-10
06934184004315MultiStage®MSO-1255-082025-02-10

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Primary DI, Brand, Company table
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00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
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15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
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04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27