FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694025331
Brand
OsteoMed
Company
OSTEOMED LLC
Model
386-1016
Catalog number
386-1016
Device description
EnCompass 16mm Drill Guide
Published
2016-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694025331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694025331008456940253318456940253310845694025331

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter16Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0275 Degrees Fahrenheit

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

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Primary DI, Brand, Company table
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G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007840HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
00810005668095TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668101TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668118TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668187TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963565TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963572TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
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00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11