FDA.reportPublic FDA data

Y-Connector

Primary DI
04560264562080
Brand
Y-Connector
Company
NAKANISHI INC.
Model
Y-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

Product Codes#

Code, Name table
CodeName
KMWHANDPIECE, ROTARY BONE CUTTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264562080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264562080045602645620804560264562080

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool and dry place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690710546
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22
04589551388929VA170LUX-SCVA170LUX-SC2026-02-13
04589551388936VA170-SCVA170-SC2026-02-13
04589551388981Potentiometer SetPotentiometer Set2026-02-13
04589551389452VariosG162026-02-13
04589551383900VariosScaling G16 Pack2026-02-13
04589551389476Perio Kit APerio Kit A2026-02-13
04589551389483VA170VA1702026-02-13
04560264577763VA2-LUX-HP TiVA2-LUX-HP Ti2026-02-13
04589551387168Tip Cover LTip Cover L2026-01-21
04589551387151Tip Cover STip Cover S2026-01-21
04589551382828E TIP WRENCHE TIP WRENCH2026-01-21
04589551387144VariosCR-12026-01-21
04560264579958CLA-10CLA-102026-01-21
045895513889743 Mode Select Switch3 Mode Select Switch2026-01-21
04589551383863VariosG12022-12-13
04589551383870VariosG42022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00845694006408OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006415OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006422OsteoMedOSTEOMED LLCKMW2017-09-22