FDA.report

OsteoMed

Primary DI
00845694053310
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0899
Catalog number
220-0899
Device description
2.0mm ICON Rainbow Drill, Long Cannula, J-Latch
Published
2016-07-21
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
true

Related Records

Contact Domains

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694053310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694053310008456940533108456940533100845694053310

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter2Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
00810168190457NAPACIFIC INSTRUMENTS, INC.HTW2026-05-26
04048844358617MUTARS®implantcast GmbHHTW2026-03-24
04048844358716MUTARS®implantcast GmbHHTW2026-03-24
04048844358792MUTARS®implantcast GmbHHTW2026-03-24
04048844358839MUTARS®implantcast GmbHHTW2026-03-24
00840314270245gSourceGSOURCE LLCHTW2026-03-20
00840314270252gSourceGSOURCE LLCHTW2026-03-20
00840314270269gSourceGSOURCE LLCHTW2026-03-20
00763000884543n/aMEDTRONIC SOFAMOR DANEK, INC.HTW2026-03-13
00888867500891Arthrex®ARTHREX, INC.HTW2026-03-13
00888867500921Arthrex®ARTHREX, INC.HTW2026-03-13
00817438028618N/AOmega Surgical Instruments IncHTW2026-03-03
06974940307007endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307021endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
00889024706484Vanguard®Biomet Orthopedics, LLCHTW2026-02-27
00841435124929TecometTECOMET INC.HTW2026-02-26
08053782783731BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-02-19
00190376709253AMP IIALPHATEC SPINE, INC.HTW2026-02-18
00810112597455TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00810112598896TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTW2026-02-10
00199150062973Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-02-09
00889024683891G7® Revision Acetabular SystemZimmer, Inc.HTW2026-02-05
04026575282883General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575299188TrabecuLink Augments InstrumentsWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575414932General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
04026575427130General InstrumentWALDEMAR LINK GmbH & Co. KGHTW2026-02-02
00810056993122corraCarlsmed, Inc.HTW2026-01-30
00810056993153corraCarlsmed, Inc.HTW2026-01-30
00810056993160corraCarlsmed, Inc.HTW2026-01-30