AccessGUDID - DEVICE: MULTI-GUIDE (34546540259067)

GUDID

Device Identifier (DI) Information

Brand Name: MULTI-GUIDE
Version or Model: 62-20022
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62-20022
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 34546540259067
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2025
Device Count: 2
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: SELF-DRILLING PINS, AUTO PILOT

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:	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?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQN	EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960297	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
Device Size Text, specify: Diameter: 2.0 Millimeter
Length: 10.0 Millimeter
Length: 90.0 Millimeter

Device Record Status

Public Device Record Key: 38d773ac-3881-4905-87bf-83f92b564980
Public Version Date: July 14, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2015