AccessGUDID - DEVICE: VIPER (10705034034768)

GUDID

Device Identifier (DI) Information

Brand Name: VIPER
Version or Model: 175710160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 175710160
Company Name: Medos International Sàrl

Primary DI Number: 10705034034768
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: VIPER F2 FACET FIXATION SYSTEM WASHER 16mm

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?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRW	SYSTEM, FACET SCREW SPINAL DEVICE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101762	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: 43189524-156e-48ca-977f-a0a66de84dfd
Public Version Date: July 08, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015