BASAL DORSAL PLATE

Basic Information

• Brand Name: BASAL DORSAL PLATE
• Primary DI: 10381780043317
• Version / Model: 116010SND
• Catalog Number: 116010SND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: c5fdff21-8fe8-4aa9-b90d-c84b76588ba4
• Distribution End Date: 2018-02-28

Device Description

The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes. It is implanted using Newdeal locking system fixation screws and washers. The screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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; 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780043317	GS1
Secondary	M248116010SND1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			17.7mm width x 27.4mm length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place.