AccessGUDID - DEVICE: HINGE PEDIATRIC PLATING SYSTEM (07540194004321)

GUDID

Device Identifier (DI) Information

Brand Name: HINGE PEDIATRIC PLATING SYSTEM
Version or Model: HPS030-C-PKG2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HPS030-C-PKG2
Company Name: Pega Medical Inc

Primary DI Number: 07540194004321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 257315713 *Terms of Use

Device Description: Cannulated Screw 30mm Length

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?
44896	Growth-correction orthopaedic fixation plate kit	A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone
HRS	Plate, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090440	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
Length: 30 Millimeter

Device Record Status

Public Device Record Key: 7840c2eb-4157-4165-89fd-282080f8d4c6
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: December 07, 2016