AccessGUDID - DEVICE: N/A (00889024367289)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 00-0032-015-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-0032-015-00
Company Name: SYNVASIVE TECHNOLOGY, INC.

Primary DI Number: 00889024367289
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618258974 *Terms of Use

Device Description: Full Length Sling

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:	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?
13624	Leg sling	A collection of non-sterile bands/straps typically suspended from the user's waist and neck/shoulder, and terminating around an injured leg, intended to support and immobilize the leg during the healing process. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HST	Apparatus, Traction, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 395a82d8-3f25-4631-82b6-9ff7b94ebbe0
Public Version Date: October 01, 2020
Public Version Number: 1
DI Record Publish Date: September 23, 2020