FDA.reportPublic FDA data

PolypVac®

Primary DI
00862519000304
Brand
PolypVac®
Company
LAURIMED, LLC
Model
3.3mm Microdebrider
Catalog number
FG-000016
Published
2016-10-10
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
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862519000311PackageGS14In Commercial Distribution
00862519000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862519000311008625190003118625190003110862519000311
00862519000304008625190003048625190003040862519000304

GMDN Terms#

Term, Definition table
TermDefinition
ENT shaver system handpieceA handle with attached cutting blade that is a component of a line-powered ENT shaver system and designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It is typically connected to and regulated through a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and may be used in combination with appropriate endoscopic devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622446255
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862519000328PolypVac®4.0mm MicrodebriderFG-0000172016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2023-10-12
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAERL2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAERL2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAERL2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAERL2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAERL2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAERL2023-02-22
07630055507853Cable for HS-Micro-Motor,largeBien-Air Surgery SAERL2023-02-22
07630055507860Perforator MotorBien-Air Surgery SAERL2023-02-22
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAERL2023-02-17
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505828BASCH-1 MicromotorBien-Air Surgery SAERL2023-02-10