AccessGUDID - DEVICE: Bone Management (E0HM36BMP0000201)

GUDID

Device Identifier (DI) Information

Brand Name: Bone Management
Version or Model: MP20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MP20
Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung

Primary DI Number: E0HM36BMP0000201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 318034329 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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, 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 (e.g., dental regeneration membrane fixation); 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 [?]
K240321	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: 54b1f01d-e52b-44c1-a1d0-36a722589631
Public Version Date: November 26, 2024
Public Version Number: 1
DI Record Publish Date: November 18, 2024