FDA.reportPublic FDA data

GYRUS ACMI, INC

Primary DI
00821925019935
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
230559
Device description
FIBER OPTIC LIGHT CABLE 8' LONG 4.0 MM DIAMETER
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCMENDOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935235000ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYSmith & Nephew Richards, Inc.1995-03-23GCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925019935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925019935008219250199358219250199350821925019935

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207007822NARichard Wolf GmbHGCM2024-08-19
04055207008393NARichard Wolf GmbHGCM2024-08-19
04055207058985NARichard Wolf GmbHGCM2024-08-19
00198506001970ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002137ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002243ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002298ELMEDELMED INCORPORATEDGCM2024-04-24
00198506002311ELMEDELMED INCORPORATEDGCM2024-04-24
00842180187597ELMEDELMED INCORPORATEDGCM2024-04-09
00842180185685ELMEDELMED INCORPORATEDGCM2024-02-20
04053755125999DOUBLE INSUFFLATION BULBHeine Optotechnik GmbH & Co. KGGCM2022-12-12
04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062906PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062913PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062920PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062937PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062944PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04953170393112DVI CABLE 3MOLYMPUS MEDICAL SYSTEMS CORP.GCM2020-05-27
04055207065761NARichard Wolf GmbHGCM2020-05-06
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
00842180135970ELMEDELMED INCORPORATEDGCM2019-04-22
00842180135932ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135949ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135963ELMEDELMED INCORPORATEDGCM2019-04-15
04055207011652NARichard Wolf GmbHGCM2017-07-21
04055207058015NARichard Wolf GmbHGCM2017-07-21
04055207058022NARichard Wolf GmbHGCM2017-07-21