FDA.reportPublic FDA data

GYRUS ACMI, INC

Primary DI
00821925026506
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
70231057
Device description
REPL LAMP FOR ENTIRE 150 ILLUMINATOR.
Published
2018-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925026506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925026506008219250265068219250265060821925026506

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095556145zumaxZumax Medical Co., LTDEBA2026-07-06
06945095541455zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548157zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548317zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548454zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548515zumaxZumax Medical Co., LTDEBA2026-06-03
06945095546931zumaxZumax Medical Co., LTDEBA2026-06-01
06945095546993zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547037zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547204zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547433zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547440zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547778zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547938zumaxZumax Medical Co., LTDEBA2026-06-01
06945095544258zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544449zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544623zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544883zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545019zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545033zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545040zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545057zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545217zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545231zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545521zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545538zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545569zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545729zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545903zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545934zumaxZumax Medical Co., LTDEBA2026-05-20