AccessGUDID - DEVICE: MEITAC (E0HM79MT0019)

GUDID

Device Identifier (DI) Information

Brand Name: MEITAC
Version or Model: BMPBA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMPBA
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: E0HM79MT0019
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318034329 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46640	Craniofacial bone tack, non-bioabsorbable	A small, sterile, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZL	Screw, Fixation, Intraosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130682	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 87fcfd3f-1d2d-431d-aa5e-9b550a7450dc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 13, 2015