AccessGUDID - DEVICE: ISOLA (10705034009841)

GUDID

Device Identifier (DI) Information

Brand Name: ISOLA
Version or Model: 30041524
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 30041524
Company Name: DEPUY SPINE, LLC

Primary DI Number: 10705034009841
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 107105876 *Terms of Use

Device Description: ANTERIOR ISOLA SPINE SYSTEM SINGLE HOLE STAPLE

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?
61668	Orthopaedic bone staple, non-adjustable, non-sterile	A non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943819	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: c8d36943-a960-4d20-9e57-5330658f79bc
Public Version Date: August 31, 2018
Public Version Number: 5
DI Record Publish Date: September 24, 2015