AccessGUDID - DEVICE: Disposable Dilators (00878953005355)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Dilators
Version or Model: 720117-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720117-01
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953005355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1) 13-14 mm Dilator 1) 15-16 mm Dilator

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:	Yes
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?
58389	Corpus cavernosum dilator, single-use	A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGA	Penile implant surgical accessories

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: 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 to 16 mm
Device Size Text, specify: 13 to 14 mm
Device Size Text, specify: 11 to 12 mm
Device Size Text, specify: 9 to 10 mm

Device Record Status

Public Device Record Key: 7ab58aaf-86fb-4d02-a73d-870c8f7bcfb1
Public Version Date: November 04, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2014