FDA.reportPublic FDA data

Bovie

Primary DI
00607151009939
Brand
Bovie
Company
BOVIE MEDICAL CORPORATION
Model
E15614
Catalog number
E15614
Device description
Loop, 20 x 12mm, 4.0” length
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151009936PrimaryGS10
00607151009939Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715100993610607151009936
00607151009939006071510099396071510099390607151009939

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079940465
Device count
10
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
false
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
00607151009854BovieE15646E156462020-11-16
00607151009861BovieE15644E156442020-11-16
00607151009878BovieE15596E155962020-11-16
00607151009885BovieE15606E156062020-11-16
00607151009892BovieE15616E156162020-11-16
00607151009908BovieE15626E156262020-11-16
00607151009915BovieE15594E155942020-11-16
00607151009922BovieE15604E156042020-11-16
00607151009946BovieE15624E156242020-11-16
00607151009953BovieE16512E165122020-11-16
00607151009960BovieE16514E165142020-11-16
10607151010796BOVIEBA3350ABA3350A2016-10-07
10607151010819BOVIEBA3390ABA3390A2016-10-07
10607151010826BOVIEBA3390NABA3390NA2016-10-07
10607151010833BOVIEBA3350NABA3350NA2016-10-07
10607151010840BOVIEBA2455NABA2455NA2016-10-07
10607151010857BOVIEBA1860NABA1860NA2016-10-07
10607151007604J-PLASMA® GS-270CGS-270C2016-09-21
10607151007819J-PLASMA® GS-018CGS-018C2016-09-21
10607151009455J-PLASMA® BVX-270BBVX-270B2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113234407BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113234414BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236838BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236845BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236876BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236883BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236906BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236920BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236944BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236951BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236968BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236975BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236982BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236999BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237002BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237019BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237026BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237033BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237057BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237071BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237095BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237125BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237149BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237156BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237163BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237170BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237187BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237194BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237200BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237217BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21