FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694055758
Brand
OsteoMed
Company
OSTEOMED LLC
Model
234-2022
Catalog number
234-2022
Device description
ICON, 2.0 x 22mm Screw, Self-Tapping
Published
2015-08-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694055758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694055758008456940557588456940557580845694055758

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Moist Heat or Steam Sterilization

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
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 DI, Brand, Model table
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 DI, Brand, Company table
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