AccessGUDID - DEVICE: Large Fragment Active Plating System (00866204000235)

GUDID

Device Identifier (DI) Information

Brand Name: Large Fragment Active Plating System
Version or Model: 00-505-000-26
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Incipio Devices

Primary DI Number: 00866204000235
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 042094056 *Terms of Use

Device Description: 5mm Locking Screw, 26mm

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?
34003	Hip internal fixation system	An assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142938	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: d31496c5-c415-4f7d-bed6-12c13dac6d40
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: February 24, 2016