FDA.reportPublic FDA data

GYRUS ACMI, INC

Primary DI
00821925003446
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
14BX
Device description
"Guidewire 0.038"" (0.97 mm) x 150 cm Super Stiff Body, 9 cm Straight Tip (5/PK)"
Published
2024-07-24
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
EYAStylet, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYAStylet, UreteralGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925009356PackageGS15In Commercial Distribution
00821925003446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925009356008219250093568219250093560821925009356
00821925003446008219250034468219250034460821925003446

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586UR96286210Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
G586UR96286410Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
00842962125588HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125595HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125601HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125618HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125625HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125632HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125649HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125656HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125670HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125687HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125694HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125700HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125717HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125724HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125731HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125748HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125755HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125762HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125809HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125816HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125823HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842331134531Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00842331135897Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
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