FDA.reportPublic FDA data

NA

Primary DI
04055207008751
Brand
NA
Company
Richard Wolf GmbH
Model
452600
Catalog number
4526.00
Device description
HEADLAMP reusable
Published
2018-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
04055207008751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207008751040552070087514055207008751

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
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
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

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
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
00841645132004ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26