FDA.report

OsteoMed

Primary DI
00845694005692
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0022
Catalog number
220-0022
Device description
1.2mm Screwdriver Shaft, Manual
Published
2017-09-22
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
00845694005692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694005692008456940056928456940056920845694005692

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

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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
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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