AccessGUDID - DEVICE: Baby Gorilla®/Gorilla® Plating System (00889795099129)

GUDID

Device Identifier (DI) Information

Brand Name: Baby Gorilla®/Gorilla® Plating System
Version or Model: P53-212-0006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P53-212-0006
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795099129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: Gorilla, Ankle Fx., Anterior Distal Tibi Plate, 15 Hole, TiA

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61573	Orthopaedic fixation plate, non-bioabsorbable, non-sterile	A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.	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: 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: ad211b04-c06b-4aec-a85d-7ee5b3f03fad
Public Version Date: April 22, 2025
Public Version Number: 3
DI Record Publish Date: September 14, 2022