EMERYGLIDE

Primary DI
04260461060036
Brand
EMERYGLIDE
Company
Nano4Imaging GmbH
Model
EG18008901
Device description
EmeryGlide™ is a sterile, disposable guidewire for the introduction and/or placement of diagnostic or interventional devices. EmeryGlide™ is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of EmeryGlide™ is marked with discrete ring markers for MRI and X-Ray visibility and comes in an angled configuration. EmeryGlide™ is supplied sterile and non-pyrogenic. EmeryGlide™’s diameter is 0.035” (0.89 mm).
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253262000EmeryGlide™ (EG18008901)Nano4imaging GmbH2026-03-06DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260461060033PackageGS11In Commercial Distribution
24260461060030PackageGS15In Commercial Distribution
04260461060036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426046106003314260461060033
2426046106003024260461060030
04260461060036042604610600364260461060036

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0
Guidewire Length0

Regulatory Flags#

DUNS number
342134732
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
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
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10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
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10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07