AccessGUDID - DEVICE: DynafitSystem (03701173705576)

GUDID

Device Identifier (DI) Information

Brand Name: DynafitSystem
Version or Model: I020000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I020000
Company Name: NEOSTEO

Primary DI Number: 03701173705576
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 261106831 *Terms of Use

Device Description: Interphalangeal Joint Fusion Device, Size S, 0°, 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":	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?
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
HWC	Screw, 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Device must be stored in a place protected from light and humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size S – 0°

Device Record Status

Public Device Record Key: 63028e14-29a4-4a0c-8053-e1062689b996
Public Version Date: March 06, 2025
Public Version Number: 3
DI Record Publish Date: December 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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