FDA.reportPublic FDA data

ASSI

Primary DI
00841645132004
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.FOHL22326
Device description
Fiber Optic Headlight with Cable3.5mm dia. F/O Cable, Dbl. Lens SystemAdjustable Cushioned Headband
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645132004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645132004008416451320048416451320040841645132004

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn fibreoptic lightA fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
055870299
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841645131991ASSIASSI.FOC178/752020-06-30
00841645119371ASSIASSI.125262020-06-25
00841645119425ASSIASSI.129262020-06-25
00841645103325ASSIASSI.FOAL2682016-09-26
00841645131830ASSIASSI.FOAE1632016-09-26
00841645131847ASSIASSI.FOAE1642016-09-26
00841645131854ASSIASSI.FOAE1652016-09-26
00841645131861ASSIASSI.FOAHL2802016-09-26
00841645131878ASSIASSI.FOAL2602016-09-26
00841645131885ASSIASSI.FOAL2612016-09-26
00841645131892ASSIASSI.FOAL2622016-09-26
00841645131908ASSIASSI.FOAL2662016-09-26
00841645131915ASSIASSI.FOAL2672016-09-26
00841645131922ASSIASSI.FOAL2712016-09-26
00841645131939ASSIASSI.FOC158/62016-09-26
00841645131946ASSIASSI.FOC158/752016-09-26
00841645131953ASSIASSI.FOC158/982016-09-26
00841645131960ASSIASSI.FOC171/62016-09-26
00841645131977ASSIASSI.FOC171/752016-09-26
00841645131984ASSIASSI.FOC171/982016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183500559BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183501136BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00816835023967IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023974IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023981IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023998IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024018IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024025IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024032IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024056Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024063Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023950IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023966IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023973IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023997IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024017IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024024IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024031IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024055Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024062Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
B366HDL200FIBEROPTIC HEADLUXEclerisFCT2022-06-10
00862658000326Fiberoptics Technology IncFIBEROPTICS TECHNOLOGY, INC.FCT2021-07-26
04055207008751NARichard Wolf GmbHFCT2018-10-17
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09