AccessGUDID - DEVICE: Precision™ (08714729888734)

GUDID

Device Identifier (DI) Information

Brand Name: Precision™
Version or Model: SC-9218-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 08714729888734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: M8 Adapter, 15cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
65308	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension	An implantable device intended to extend the electrical connection between a spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator and a lead(s). It typically includes small connectors to enable attachment to the lead(s) and pulse generator, and a length of insulated wire; the lead(s) and pulse generator are not included.	Active	true

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	202
P030017	357
P030017	363
P030017	365

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: 15 cm Effective Length

Device Record Status

Public Device Record Key: 9228d7bb-9052-4710-8130-381cab379ad3
Public Version Date: July 02, 2025
Public Version Number: 5
DI Record Publish Date: December 14, 2015