FDA.reportPublic FDA data

Bovie

Primary DI
00840113242580
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ST10
Device description
Surch-Lite 10" Sterile
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00840113242580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113242580008401132425808401132425800840113242580

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.

Contacts#

Phone, Email table
PhoneEmail
8883647004customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840113242573BovieASPEN SURGICAL PRODUCTS, INC.FTF2026-09-04
00840113242702BovieASPEN SURGICAL PRODUCTS, INC.FTF2026-09-04
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
00607151069100BovieASPEN 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