AccessGUDID - DEVICE: Precision ™ (08714729121688)

GUDID

Device Identifier (DI) Information

Brand Name: Precision ™
Version or Model: SC-6350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC-6350
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 08714729121688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: Adhesive Kit

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?
46219	Medical device adhesive	A substance primarily intended to promote the bonding of two surfaces in the manufacture of medical devices (e.g., active implantable devices). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
QRB	Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030017	000
P030017	357
P030017	363

Device Exempt from Premarket Submission: No 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: d8266334-2e02-42a5-a904-5e3d4ad913de
Public Version Date: March 25, 2024
Public Version Number: 4
DI Record Publish Date: August 20, 2015