FDA.reportPublic FDA data

WOODPECKER

Primary DI
06944843605012
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
ULTRASURGERY
Device description
Piezo Bone Surgery
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944843605012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944843605012069448436050126944843605012

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
545272577
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944843619057EDEGENDOEDGEAPEX HP2025-03-11
06944843619071EDEGENDOEDGEPACK2025-03-11
06944843619088EDEGENDOEDGEFLOW2025-03-11
06944843619095EDEGENDOEDGEAPEX2025-03-11
06944843605982woodpeckerK-Po2024-10-18
06944843611587woodpeckerAP-A2024-10-18
06944843611594DTEAP-A2024-10-18
06944843611600woodpeckerAP-B2024-10-18
06944843611617DTEAP-B2024-10-18
06944843617510DTEU6 LED2024-10-18
06944843655987DTEPT-B2024-10-18
06944843657721DTEi-Polish2024-10-18
06944843657745DTEK-Po2024-10-18
06944843658155woodpeckerV V Light2024-10-18
06944843658728DTELED.B2024-10-18
06944843659916woodpeckerUDS-T LED2024-10-18
06944843660165DTED8 LED2024-10-18
06944843662596woodpeckerProphy-Mini2024-10-18
06944843600987DTEImplant-X2024-10-17
06944843600994woodpeckerImplanter2024-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E322033800150MECTRONMECTRON SPADZI2026-02-18
E322033800160MECTRONMECTRON SPADZI2026-02-18
E322034000110MECTRONMECTRON SPADZI2026-02-18
E322034000120MECTRONMECTRON SPADZI2026-02-18
E322034000130MECTRONMECTRON SPADZI2026-02-18
E322048000111010MECTRONMECTRON SPADZI2026-02-18
E322048000121010MECTRONMECTRON SPADZI2026-02-18
00810044841459Round Bur one size lengthOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842722HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842739HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842845OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842852OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842869OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843125HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843132HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843149HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843156HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843163HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843170HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843187HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843194HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843200HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843224HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842142OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842159OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842166OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842173OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842180OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842197OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842203OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24