FDA.report

OsteoMed

Primary DI
00845694094481
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0644-113
Catalog number
220-0644-113
Device description
213-1608, Grey ID Tag, 5x2H LG
Published
2016-10-03
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
false

Related Records

Contact Domains

Product Codes

CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694094481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694094481008456940944818456940944810845694094481

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.

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
08800000987293Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987309Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987316Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987323Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987330Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987347Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987354Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987361Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800040644095Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040644118Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040644132Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040654599Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800040655848OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655862OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655886OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655909OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
ESAM23053120STOMA®Storz am Mark GmbHDZL2025-04-30
D765PFTK100Pro-fix™ Precision Fixation SystemOsteogenics Biomedical IncDZL2025-03-31
00888118142894LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2025-01-23
00888118142900LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2025-01-23
00888118145222LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145239LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145246LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145253LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145260LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145277LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
08056992093010MCBio Supertack Tack 3mm - N.5MC BIO SRLDZL2024-12-17
08056992093027MCBio Supertack Tack 3mm - N.10MC BIO SRLDZL2024-12-17
08056992093034MCBio Supertack Tack 4mm - N.5MC BIO SRLDZL2024-12-17
08056992093041MCBio Supertack Tack 5mm - N.5MC BIO SRLDZL2024-12-17