FDA.report

OsteoMed

Primary DI
00845694090865
Brand
OsteoMed
Company
OSTEOMED LLC
Model
299-2008
Catalog number
299-2008
Device description
2.0 x 8mm IMF AutoDrive Screw
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694090865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694090865008456940908658456940908650845694090865

GMDN Terms

TermDefinition
Craniofacial bone wire/barA length of metal (e.g., stainless steel) intended to stabilize bony fragments (fractured bone) in the oral cavity and/or stabilize injured teeth. Stabilization occurs by direct application of the device to the bone/teeth (e.g., by wrapping the ligature around fractured bone segments and locking the ends together). The device may be used for intermaxillary fixation, maxillomandibular fixation, or other forms of jaw immobilization. This is a single-use device.

Device Sizes

TypeValueUnit
Length8Millimeter

Sterilization Methods

Method

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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08800000987330Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
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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
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08800040655909OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
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