AccessGUDID - DEVICE: SURFIX (10381780049005)

GUDID

Device Identifier (DI) Information

Brand Name: SURFIX
Version or Model: 285324ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 285324ND
Company Name: NEWDEAL

Primary DI Number: 10381780049005
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: Titanium alloy Newdeal non sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis 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:	Yes
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?
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must 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 [?]
K060474	000
K060476	000
K063820	000
K070241	000
K070447	000
K073375	000
K091609	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: 3.5mm diam. x 24mm length

Device Record Status

Public Device Record Key: 88622ea2-1610-45fd-af13-28b43a4fdc79
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: October 09, 2017