FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925007505
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
RHL-1
Device description
Large Replacement Handle And Knob Assembly
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
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890328000ADULT RESECTOSCOPECircon Video1990-02-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925007505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007505008219250075058219250075050821925007505

GMDN Terms#

Term, Definition table
TermDefinition
Device control handling knobA hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALFAS2026-07-10
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08904148101525ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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08904148101600ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101617ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101624ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101822ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101839ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101846ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101853ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101860ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101877ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101891ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102157ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102164ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102379ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148103628ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105868ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105875ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105882ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106322ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106346ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21