AccessGUDID - DEVICE: Viper® Distal Volar Radius Plating System (10381780064343)

GUDID

Device Identifier (DI) Information

Brand Name: Viper® Distal Volar Radius Plating System
Version or Model: VIPERSET
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VIPERSET
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780064343
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The VIPERSET consists of a distal volar radius plate with the option of either a 4-hole or 6-hole plate with left or right configuration, screws in diameter size 2.7mm or 3.5mm, and instruments to assist in the implantation. The set is generally indicated for reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

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:	No
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?
61689	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile	A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. 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 [?]
K041461	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1a71514e-65a9-498d-b2bd-e8810eddfc88
Public Version Date: February 19, 2024
Public Version Number: 7
DI Record Publish Date: August 15, 2015