Bone Management

Primary DI
E0HM39MSS100401
Brand
Bone Management
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
MSS10 4
Catalog number
MSS10 4
Device description
MICRO-SCREW ST Ø1.0 L 4.0
Published
2022-07-08
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201210000The Micro Screw System, Micro Screw System BasicHager& Meisinger GmbH2021-10-08DZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E0HM39MSS100401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, non-sterileA small, non-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 treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device 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 surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags#

DUNS number
318034329
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDRS220011OKTAGON Dental Implant BL RC22001220012015-10-01
EDRS220021OKTAGON Dental Implant BL RC22002220022015-10-01
EDRS220031OKTAGON Dental Implant BL RC22003220032015-10-01
EDRS220041OKTAGON Dental Implant BL RC22004220042015-10-01
EDRS220051OKTAGON Dental Implant BL RC22005220052015-10-01
EDRS220061OKTAGON Dental Implant BL RC22006220062015-10-01
EDRS220071OKTAGON Dental Implant BL RC22007220072015-10-01
EDRS220081OKTAGON Dental Implant BL RC22008220082015-10-01
EDRS220091OKTAGON Dental Implant BL NC22009220092015-10-01
EDRS220101OKTAGON Dental Implant BL NC22010220102015-10-01
EDRS220111OKTAGON Dental Implant BL NC22011220112015-10-01
EDRS220121OKTAGON Dental Implant BL NC22012220122015-10-01
EDRS220131OKTAGON BL NC Cover screw GH 0.0 mm22013220132017-01-27
EDRS220141OKTAGON BL NC Cover screw GH 0.5 mm22014220142017-01-27
EDRS220171OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm22017220172017-01-27
EDRS220181OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 3.5 mm22018220182017-01-27
EDRS220191OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 5.0 mm22019220192017-01-27
EDRS220201OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 2.0 mm22020220202017-01-27
EDRS220211OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 3.5 mm22021220212017-01-27
EDRS220221OKTAGON BL NC Healing abutment, conical Ø4.8 mm GH 5.0 mm22022220222017-01-27

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