FDA.report

Bovie

Primary DI
10607151008922
Brand
Bovie
Company
BOVIE MEDICAL CORPORATION
Model
SEPA
Catalog number
SEPA
Device description
ELECTROSURGERY PENCIL ADAPTER WITH 3/8” (.952cm) X 1” (30.48CM) TUBING WITH 3/8” (.952cm) TO 3/8” (.952cm) CONNECTOR
Published
2016-09-16
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

Related Records

Product Codes

CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607151008922PackageGS125In Commercial Distribution
00607151008925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715100892210607151008922
00607151008925006071510089256071510089250607151008925

GMDN Terms

TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
079940465
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10607151006737BovieA827BPA827BP2017-02-14
10607151011526BovieAD-330-A8AD-330-A82017-03-30
10607151011601BovieAD-770-A8AD-770-A82017-03-30
10607151011649BovieAD-770R-A8AD-770R-A82017-03-30
10607151011694BovieA5A52017-03-30
10607151012028BovieAD-330-A5AD-330-A52017-03-30
10607151012042BovieAD-330R-A5AD-330R-A52017-03-30
10607151012073BovieAD-770-A5AD-770-A52017-03-30
10607151012097BovieAD-770R-A5AD-770R-A52017-03-30
10607151001114BovieIDS-200IDS-2002016-10-13
10607151001121BovieIDS-300IDS-3002016-10-13
10607151002784BovieA2250-LOANERA2250-LOANER2016-10-13
10607151002791BovieIDS-300-LOANERIDS-300-LOANER2016-10-13
10607151002807BovieIDS-200-LOANERIDS-200-LOANER2016-10-13
10607151003101BovieA3250-LOANERA3250-LOANER2016-10-13
10607151004726BovieIDS-400IDS-4002016-10-13
10607151005327BovieGS100GS1002016-10-13
10607151005334BovieA940A9402016-10-13
10607151005365BovieA940-LOANERA940-LOANER2016-10-13
10607151005525BovieA2250-DEMOA2250-DEMO2016-10-13

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