AccessGUDID - DEVICE: BASAL DORSAL PLATE (10381780043331)

GUDID

Device Identifier (DI) Information

Brand Name: BASAL DORSAL PLATE
Version or Model: 116110SND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 116110SND
Company Name: NEWDEAL

Primary DI Number: 10381780043331
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

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

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":	Yes
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?
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place.

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 16ab2de3-b9c1-49ce-a3c5-de8ad1a7ee2d
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: October 09, 2017