AccessGUDID - DEVICE: SmartLock (07613154700929)

GUDID

Device Identifier (DI) Information

Brand Name: SmartLock
Version or Model: 54-25286S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 54-25286S
Company Name: Stryker Trauma SA

Primary DI Number: 07613154700929
Issuing Agency: GS1
Commercial Distribution End Date: July 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: DORSAL LOCKING DR PLATE, MED,RIGHT

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?
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Number of Screw Holes: 10.0 Holes

Device Record Status

Public Device Record Key: f60e7a1a-4113-42e4-9c22-9c8c14a1a51f
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015