FDA.reportPublic FDA data

DELTA X CPP

Primary DI
04053755203321
Brand
DELTA X CPP
Company
Heine Optotechnik GmbH & Co. KG
Model
00
Catalog number
K-000.34.237
Device description
contact plate
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755203321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755203321040537552033214053755203321

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4908152380info@heine.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755207596GAMMA 3.2 VET000G-000.09.9472026-07-22
04053755200122visionPRO Set Mac000F-270.95.8622026-06-24
04053755213092MEDUVISION Set Mac000WM 104112026-06-23
04053755213108MEDUVISION Mac 3 (10x)000WM 104132026-06-23
04053755213115MEDUVISION Mac 2 (10x)000WM 104122026-06-23
04053755213122MEDUVISION Mac 4 (10x)000WM 104142026-06-23
04053755213139MEDUVISION HyMac 3 (10x)000WM 104152026-06-23
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00814005023526RADBL25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023533RADBLC1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023540RADFILM5QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023571RADHU2QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023595RADHUM4QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023618RADINST1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024172RADC25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024189RADFILM6QUALITY ASPIRATORS, INC.KYT2025-02-27
008140050242572 Pin Detachable CableQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024288M-CZQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024295M-ORTTL AssemblyQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024301M-COQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024370M-KEQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024387M-HBQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024394M-ORQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024400M-QFQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024431M-SUQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024448M-SUTTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024455M-SVQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024462M-TTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024479RADFIL1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024486RADFIL2QUALITY ASPIRATORS, INC.KYT2025-02-27