FDA.reportPublic FDA data

DIEGO ELITE

Primary DI
00821925038530
Brand
DIEGO ELITE
Company
Gyrus ACMI, LLC
Model
MM4000SS
Device description
SHAVER BLADE, 4 MM, 40 DEGREES monopolar distal suction, T/A MALLEABLE, MONOPOLAR DIEGO ELITE
Published
2016-10-14
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123429000OLYMPUS ENERGY POWER SYSTEM (EPS)Gyrus Acmi, Inc.2013-04-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925027978PackageGS15In Commercial Distribution
00821925038530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925027978008219250279788219250279780821925027978
00821925038530008219250385308219250385300821925038530

GMDN Terms#

Term, Definition table
TermDefinition
ENT shaver systemAn assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.

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
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14