FDA.reportPublic FDA data

WOODPECKER

Primary DI
06944843606583
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
US1R
Device description
Dental ultrasonic surgical system handpiece tip
Published
2016-09-29
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
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944843606583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944843606583069448436065836944843606583

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical system handpiece tipA removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). 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. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization

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
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
07613353180089Instruments A P PSE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353180096Instruments PS PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353336837Instruments PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
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04560264577763VA2-LUX-HP TiNAKANISHI INC.ELC2026-02-13
04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
04589551387144VariosNAKANISHI INC.ELC2026-01-21
04560264579958CLA-10NAKANISHI INC.ELC2026-01-21
045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21