MEITAC BMPBA

GUDID E0HM79MT0019

The system MEITAC consist of Tacs and neccessary accessories. The system contains 20 Tacs. Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. The Tacs consist of titanium alloy Grade 5 and are delivered non sterile.

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Craniofacial bone tack, non-bioabsorbable
Primary Device IDE0HM79MT0019
NIH Device Record Key87fcfd3f-1d2d-431d-aa5e-9b550a7450dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEITAC
Version Model NumberBMPBA
Catalog NumberBMPBA
Company DUNS318034329
Company NameHager & Meisinger Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (303) 268-5400
Emailinfo@meisingerusa.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE0HM79MT0019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLScrew, Fixation, Intraosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E0HM79MT0019]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-13

Devices Manufactured by Hager & Meisinger Gesellschaft mit beschränkter Haftung

E0HMM10604010111 - Endo Dental Bur2023-06-20 Endo Dental Bur
E0HMM10604010211 - Endo Dental Bur2023-06-20 Endo Dental Bur
E0HM39MSS100401 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 4.0
E0HM39MSS100601 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 6.0
E0HM39MSS100801 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 8.0
E0HM39MSS101001 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 10.0
E0HM39MSS101201 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 12.0
E0HM39MSS101401 - Bone Management2022-07-18 MICRO-SCREW ST Ø1.0 L 14.0

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