FDA.report

OsteoMed

Primary DI
00845694032698
Brand
OsteoMed
Company
OSTEOMED LLC
Model
320-0408
Catalog number
320-0408
Device description
FPS .189 x 9" Smooth Steinman Pin
Published
2015-05-08
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
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694032698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694032698008456940326988456940326980845694032698

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter4.8Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Stored at controlled room temperature

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
true
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

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04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
00810158218772PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00810158218819PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
B356DF370170American MedicalsAmerican MedicalsHXK2026-01-30
04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
00840217910125Wiggins medicalEbner Medical, LLCHXK2025-12-10
00840217910163Wiggins medicalEbner Medical, LLCHXK2025-12-10
04058749026764NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027471NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027495NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016287INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-12-02
00757770676446Bausch + LombBausch & Lomb IncorporatedHXK2025-11-14
00841336107632Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHXK2025-09-28
00840314270078gSourceGSOURCE LLCHXK2025-09-21
00810158217065PRINCETONPrinceton Medical Group, Inc.HXK2025-09-18
00810158216792PRINCETONPrinceton Medical Group, Inc.HXK2025-09-02
04058749028232NAFehling Instruments GmbH & Co. KGHXK2025-09-01
04058749026771NAFehling Instruments GmbH & Co. KGHXK2025-08-29
00840217909822Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909839Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909853Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909860Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909884Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909907Wiggins medicalEbner Medical, LLCHXK2025-08-20