FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694007399
Brand
OsteoMed
Company
OSTEOMED LLC
Model
222-0005
Catalog number
222-0005
Device description
1.1mm Pilot Drill, 4mm Stop, 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
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
00845694007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694007399008456940073998456940073990845694007399

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089458875Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458882Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458899Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458905Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458936Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458943Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458950Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515786CMF VISIONAREVISIONARE, LLCDZL2019-02-21