AccessGUDID - DEVICE: IPP-ON (10381780045908)

GUDID

Device Identifier (DI) Information

Brand Name: IPP-ON
Version or Model: 230002SND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 230002SND
Company Name: NEWDEAL

Primary DI Number: 10381780045908
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.

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?
61687	Phalangeal joint arthrodesis implant	A small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically to manage arthritis or deformities (e.g., hammer toe), or for arthroplasty revision; it is not intended for carpal, tarsal or ankle implantation. It is typically made of metal and can be of several small designs (e.g., rod with barbs at each end, X-shaped, single or dual screw), however it is not intended to be fixed into bone with bone screws (i.e., not an intramedullary nail).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	PIN, FIXATION, SMOOTH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103623	000

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: 15.6mm length x 5.9mm width

Device Record Status

Public Device Record Key: 1e78a709-fe36-4112-9ebe-2fdd42b27434
Public Version Date: March 06, 2025
Public Version Number: 6
DI Record Publish Date: October 09, 2017