AccessGUDID - DEVICE: GIRO GROWTH MODULATION SYSTEM (07540194013484)

GUDID

Device Identifier (DI) Information

Brand Name: GIRO GROWTH MODULATION SYSTEM
Version or Model: GIN-DPG300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GIN-DPG300
Company Name: Orthopediatrics Canada ULC

Primary DI Number: 07540194013484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243298854 *Terms of Use

Device Description: DEPTH GAGE 0-100mm

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:	No
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?
32845	Surgical depth gauge, reusable	A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTJ	GAUGE, DEPTH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220190	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
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ca0de08-6aff-4197-b749-f318a5929400
Public Version Date: May 13, 2025
Public Version Number: 5
DI Record Publish Date: November 29, 2022