FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694094290
Brand
OsteoMed
Company
OSTEOMED LLC
Model
455-3408
Catalog number
455-3408
Device description
5.9mm Bur, Barrel
Published
2020-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00845694094290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694094290008456940942908456940942900845694094290

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter0.236Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.KMW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.KMW2026-01-09
04589551388813SG20MNAKANISHI INC.KMW2025-08-28
04589551388820X-SG20MLNAKANISHI INC.KMW2025-08-28
04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
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
06974267891104COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-07-04
06974267891067COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-03-30
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
04589551382446X-SG93LNAKANISHI INC.KMW2022-02-17
04589551382453X-SG93NAKANISHI INC.KMW2022-02-17
04589551382460X-SG25LNAKANISHI INC.KMW2022-02-17
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
00840117305151Plastic Overbed Table, H Base, Silver Vein, GreyDynarex CorporationKMW2021-04-22
00840117305168Plastic Overbed Table, H Base, Silver Vein, CherryDynarex CorporationKMW2021-04-22
00840117305182Plastic Overbed Table, H Base, Silver Vein, Mahogany Dynarex CorporationKMW2021-04-22
00814913029603SM3HIOSSEN, INC.KMW2021-01-20
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30