AccessGUDID - DEVICE: HALLU-FIX (10381780043577)

GUDID

Device Identifier (DI) Information

Brand Name: HALLU-FIX
Version or Model: 117450ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 117450ND
Company Name: NEWDEAL

Primary DI Number: 10381780043577
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The non sterile HALLU-C plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation. A dorsal flexion bending adjustment is possible for the HALLU-C plates. They are implanted using SNAP-OFF screws which exist in different diameters and sizes.

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?
61573	Orthopaedic fixation plate, non-bioabsorbable, non-sterile	A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021626	000
K093781	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
Special Storage Condition, Specify: Store in dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 49.3mm length x 10.9mm width

Device Record Status

Public Device Record Key: a1d5312c-b263-4697-b07a-b03558781340
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: October 09, 2017