FDA.reportPublic FDA data

Bovie

Primary DI
00607151069100
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ST10
Catalog number
ST10
Device description
SURCH-LITE ™ SURGICAL LIGHT 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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTFIlluminator, Non-Remote

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTFIlluminator, Non-RemoteGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151069107PackageGS13In Commercial Distribution
00607151069100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715106910710607151069107
00607151069100006071510691006071510691000607151069100

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

Regulatory Flags#

DUNS number
027680821
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607915142087Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONFTF2026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorAPPLIED MEDICAL RESOURCES CORPORATIONFTF2026-04-22
10607151002258BovieASPEN SURGICAL PRODUCTS, INC.FTF2017-02-10
00885380024798CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
20885380024792CARDINAL HEALTHCardinal Health 200, LLCFTF2016-12-29
00607151069056BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
00607151069155BovieASPEN SURGICAL PRODUCTS, INC.FTF2016-10-17
10607151069053BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17
10607151069107BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17
10607151069152BovieBOVIE MEDICAL CORPORATIONFTF2016-10-17