Home GUDID 00814548015637 Smart Coil
Primary DI 00814548015637
Brand Smart Coil
Company PENUMBRA, INC.
Model 400SMTHXSFT1H01
Device description SmtCoil-HelXSft, 1.5x1
Published 2016-07-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HCG DEVICE, NEUROVASCULAR EMBOLIZATION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCG Device, Neurovascular Embolization Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814548015637 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814548015637 00814548015637 814548015637 0814548015637
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization coil A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Regulatory Flags# DUNS number 191077671 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false 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 DI Brand Model Catalog Published 00810169723586 swiftMATCH Coil, Extra Soft 400SWXSFT510-A 400SWXSFT510 2026-10-01 00810169723593 swiftMATCH Coil, Extra Soft 400SWXSFT615-A 400SWXSFT615 2026-10-01 00810169723609 swiftMATCH Coil, Soft 400SWSFT610-A 400SWSFT610 2026-10-01 00810169723616 swiftMATCH Coil, Soft 400SWSFT615-A 400SWSFT615 2026-10-01 00810169723623 swiftMATCH Coil, Soft 400SWSFT715-A 400SWSFT715 2026-10-01 00810169723630 swiftMATCH Coil, Soft 400SWSFT820-A 400SWSFT820 2026-10-01 00810169723647 swiftMATCH Coil, Standard 400SWSTD408-A 400SWSTD408 2026-10-01 00810169723654 swiftMATCH Coil, Standard 400SWSTD510-A 400SWSTD510 2026-10-01 00810169723661 swiftMATCH Coil, Standard 400SWSTD515-A 400SWSTD515 2026-10-01 00810169723678 swiftMATCH Coil, Standard 400SWSTD615-A 400SWSTD615 2026-10-01 00810169723685 swiftMATCH Coil, Standard 400SWSTD620-A 400SWSTD620 2026-10-01 00810169723692 swiftMATCH Coil, Standard 400SWSTD725-A 400SWSTD725 2026-10-01 00810169723708 swiftMATCH Coil, Standard 400SWSTD830-A 400SWSTD830 2026-10-01 00810169724217 Ruby XL Coil System RBYPODXL0310-A RBYPODXL0310 2026-10-01 00810169724224 Ruby XL Coil System RBYPODXL0320-A RBYPODXL0320 2026-10-01 00810169724231 Ruby XL Coil System RBYPODXL0720-A RBYPODXL0720 2026-10-01 00810169724248 Ruby XL Coil System RBYPODXL0755-A RBYPODXL0755 2026-10-01 00810169724255 Ruby XL Coil System RBYPODXL0830-A RBYPODXL0830 2026-10-01 00810169724262 Ruby XL Coil System RBYPODXL0930-A RBYPODXL0930 2026-10-01 00810169724279 Ruby XL Coil System RBYPODXL0955-A RBYPODXL0955-A 2026-10-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810169723586 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-10-01 00810169723593 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-10-01 00810169723609 swiftMATCH Coil, Soft PENUMBRA, INC. HCG 2026-10-01 00810169723616 swiftMATCH Coil, Soft PENUMBRA, INC. HCG 2026-10-01 00810169723623 swiftMATCH Coil, Soft PENUMBRA, INC. HCG 2026-10-01 00810169723630 swiftMATCH Coil, Soft PENUMBRA, INC. HCG 2026-10-01 00810169723647 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723654 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723661 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723678 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723685 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723692 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 00810169723708 swiftMATCH Coil, Standard PENUMBRA, INC. HCG 2026-10-01 04546540688897 GDC-10 Stryker Corporation HCG 2015-09-21 04546540688910 GDC-10 Stryker Corporation HCG 2015-09-21 04546540688934 GDC-10 Stryker Corporation HCG 2015-09-21 04546540688958 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689054 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689061 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689078 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689085 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689092 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689108 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689115 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689122 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689139 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689146 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689153 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689160 GDC-10 Stryker Corporation HCG 2015-09-21 04546540689177 GDC-10 Stryker Corporation HCG 2015-09-21