FDA.report

SGO-5

Primary DI
04560264501461
Brand
SGO-5
Company
NAKANISHI INC.
Model
SGO-5
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
false
Single use
false

Related Records

Product Codes

CodeName
KMWHANDPIECE, ROTARY BONE CUTTING

Product Code Classifications

CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560264501461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560264501461045602645014614560264501461

GMDN Terms

TermDefinition
Oscillating surgical saw blade, reusableA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90? angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
690710546
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008010S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008020S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
04560264557109X-SG93LNAKANISHI INC.KMW2022-02-17
04560264557116X-SG93NAKANISHI INC.KMW2022-02-17
04560264557130X-SG25LNAKANISHI INC.KMW2022-02-17
D762KITBOPR000Implant-OneImplant Logistics, Inc.KMW2021-05-12
D762KITBOPR001Implant-OneImplant Logistics, Inc.KMW2021-05-12
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30
00845694094290OsteoMedOSTEOMED LLCKMW2020-04-28
00842528123706OsteoMedOSTEOMED LLCKMW2019-11-08
08800000995212SM3Osstem Implant Co., Ltd._Gasan BranchKMW2019-04-25
08800000995274SM3Osstem Implant Co., Ltd._Gasan BranchKMW2019-04-25
08800000995236SM3Osstem Implant Co., Ltd._Gasan BranchKMW2019-04-25
00842528114551OsteoMedOSTEOMED LLCKMW2018-10-26
00842528114568OsteoMedOSTEOMED LLCKMW2018-10-26
00842528114575OsteoMedOSTEOMED LLCKMW2018-10-26
04560264557093Ti-Max XNAKANISHI INC.KMW2018-08-20
04560264556263Surgical Angle HandpieceNAKANISHI INC.KMW2018-01-22
04560264556294Surgical Straight HandpieceNAKANISHI INC.KMW2018-01-22
00842528104163OsteoMedOSTEOMED LLCKMW2018-01-17
00845694006385OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006392OsteoMedOSTEOMED LLCKMW2017-09-22
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00845694006415OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006422OsteoMedOSTEOMED LLCKMW2017-09-22