FDA.reportPublic FDA data

Bovie

Primary DI
00607151086107
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
NS10
Catalog number
NS10
Device description
SURCH-LITE ™ MEDICAL LIGHT NON-STERILE 10'' (25.4cm)
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00607151086107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607151086107006071510861076071510861070607151086107

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11