ARCHIMEDES Biodegradable Stent

Primary DI
00850078427366
Brand
ARCHIMEDES Biodegradable Stent
Company
Q3 Medical USA LLC
Model
BPS34125MUS
Catalog number
BPS34125MUS
Device description
ARCHIMEDES Biodegradable Stent is intended to drain biliary ducts in patients indicated for biliary duct stenting.
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
K260835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260835000ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)2026-07-27FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078427366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078427366008500784273668500784273660850078427366

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary/pancreatic stentA sterile bioabsorbable tubular device intended to be implanted in an obstructed/stenosed biliary and pancreatic duct (i.e., a dual-purpose device capable of implantation at either anatomy) to temporarily maintain luminal patency. It is in the form of a non-expandable tube (not mesh-like) which may include retention barbs at each end, and is made of a synthetic polymer(s) [e.g., polydioxanone, polyurethane] which will gradually disintegrate(s) following implantation; it may be radiopaque (e.g., include barium sulfate). Disposable devices intended to assist implantation may be included.

Regulatory Flags#

DUNS number
117150469
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078427250ARCHIMEDES Biodegradable StentBPS20040MUSBPS20040MUS2026-09-18
00850078427267ARCHIMEDES Biodegradable StentBPS20060MUSBPS20040MUS2026-09-18
00850078427274ARCHIMEDES Biodegradable StentBPS20080MUSBPS20080MUS2026-09-18
00850078427281ARCHIMEDES Biodegradable StentBPS20100MUSBPS20100MUS2026-09-18
00850078427298ARCHIMEDES Biodegradable StentBPS20125MUSBPS20125MUS2026-09-18
00850078427304ARCHIMEDES Biodegradable StentBPS20150MUSBPS20150MUS2026-09-18
00850078427311ARCHIMEDES Biodegradable StentBPS20175MUSBPS20175MUS2026-09-18
00850078427328ARCHIMEDES Biodegradable StentBPS34040MUSBPS34040MUS2026-09-18
00850078427335ARCHIMEDES Biodegradable StentBPS34060MUSBPS34060MUS2026-09-18
00850078427342ARCHIMEDES Biodegradable StentBPS34080MUSBPS34080MUS2026-09-18
00850078427359ARCHIMEDES Biodegradable StentBPS34100MUSBPS34100MUS2026-09-18
00850078427373ARCHIMEDES Biodegradable StentBPS34150MUSBPS34150MUS2026-09-18
00850078427380ARCHIMEDES Biodegradable StentBPS34175MUSBPS34175MUS2026-09-18
00850078427397ARCHIMEDES Biodegradable StentBPS34200MUSBPS34200MUS2026-09-18
00850078427403ARCHIMEDES Biodegradable StentBPS34225MUSBPS34225MUS2026-09-18
00850078427410ARCHIMEDES Biodegradable StentBPS26040MUSBPS26040MUS2026-09-18
00850078427427ARCHIMEDES Biodegradable StentBPS26060MUSBPS26060MUS2026-09-18
00850078427434ARCHIMEDES Biodegradable StentBPS26080MUSBPS26080MUS2026-09-18
00850078427441ARCHIMEDES Biodegradable StentBPS26100MUSBPS26100MUS2026-09-18
00850078427458ARCHIMEDES Biodegradable StentBPS26125MUSBPS26125MUS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27