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
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

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
00816349011733ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011740ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011757ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011764ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011788ZIPwire™Lake Region MedicalEYA2020-06-30