FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528110911
Brand
OsteoMed
Company
OSTEOMED LLC
Model
299-9000
Catalog number
299-9000
Device description
QuickFix MMF Plate
Published
2019-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528110911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528110911008425281109118425281109110842528110911

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length117Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stored at controlled room temperature

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403049ActivSight Imaging Module Clean and Disinfect TrayActiv Surgical, Inc.KCT2026-05-26
00850016403063ActivSight Light Cable Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00850016403070ActivSight Imaging Module Tray for VHPActiv Surgical, Inc.KCT2026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00857387006534Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00857387006541Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00385640091183INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091190INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091206INSTRUSAFESummit Medical, Inc.KCT2026-03-24
00385640091152INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091169INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00385640091176INSTRUSAFESummit Medical, Inc.KCT2026-03-23
00199150051212Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00763000710194Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00199150015429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00199150015436CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869069CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869076CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869090CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869106CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869892CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869908CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869915CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869922CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00763000869939CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
00385640091114INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091121INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091138INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00385640091145INSTRUSAFESummit Medical, Inc.KCT2026-03-20
00653159013232CASE MEDICALCase Medical Inc.KCT2026-03-20