FDA.report

OsteoMed

Primary DI
00845694012676
Brand
OsteoMed
Company
OSTEOMED LLC
Model
450-0501
Catalog number
450-0501
Device description
Lubricant and Conditioner
Published
2016-10-14
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

Contact Domains

Product Codes

CodeName
KMWHANDPIECE, ROTARY BONE CUTTING

Product Code Classifications

CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694012676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694012676008456940126768456940126760845694012676

GMDN Terms

TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods

Method
High-level Disinfectant

Contacts

PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags

DUNS number
606417780
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
true
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 DIBrandModelCatalogPublished
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13
00842528129906OsteoMed336-9207336-92072023-10-13
00842528129913OsteoMed336-9208336-92082023-10-13

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
00845694006408OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006415OsteoMedOSTEOMED LLCKMW2017-09-22
00845694006422OsteoMedOSTEOMED LLCKMW2017-09-22