AccessGUDID - DEVICE: PANTERA PLATE, LEFT, 120mm (00816101013531)

GUDID

Device Identifier (DI) Information

Brand Name: PANTERA PLATE, LEFT, 120mm
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TO-PHP-L120
Company Name: TOBY ORTHOPAEDICS

Primary DI Number: 00816101013531
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024163331 *Terms of Use

Device Description: The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.

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):	No
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?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081608	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: df954ec7-9086-48d3-9565-7e629ecc486d
Public Version Date: November 06, 2024
Public Version Number: 3
DI Record Publish Date: August 13, 2020