FDA.report

n.a.

Primary DI
04048551213032
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
8596N
Device description
Protector
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551213032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551213032040485512130324048551213032

GMDN Terms

TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08052286590500LASER THERMAL THERAPY KIT S EELESTA SPAGEX2026-03-24
08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
00860015460639NextGen Aesthetics LHRT AESTHETICS LLCGEX2026-03-12
08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCGEX2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02