FDA.report

OsteoMed

Primary DI
00845694016841
Brand
OsteoMed
Company
OSTEOMED LLC
Model
218-0078-SP
Catalog number
218-0078-SP
Device description
NeuroPack, 1 Large Bur Hole plate
Published
2015-04-07
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
00845694016841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694016841008456940168418456940168410845694016841

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

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
true
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

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