DEVICE: Humeral screw driver shaft w.Star-Bit 10=2.8mm,(f.2.7/3.5 Screws) (EMAH10001521150)

Device Identifier (DI) Information

Humeral screw driver shaft w.Star-Bit 10=2.8mm,(f.2.7/3.5 Screws)
100-0152-115
In Commercial Distribution
100-0152-115
mahe medical gmbh
EMAH10001521150
HIBCC

1
342243334 *Terms of Use
Humeral screw driver shaft w.Star-Bit 10=2.8mm,(f.2.7/3.5 Screws)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33968 Surgical screwdriver, reusable
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HXX SCREWDRIVER
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2.8 Millimeter
Length: 100.0 Millimeter
CLOSE

Device Record Status

94323f89-f287-465e-b25a-0ae2cb3455bb
December 17, 2018
1
November 14, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+49(0)746592750
info@mahe-med.de
CLOSE