AccessGUDID - DEVICE: Resectr™ (08714729964520)

GUDID

Device Identifier (DI) Information

Brand Name: Resectr™
Version or Model: M0065907041
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M0065907041
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729964520
Issuing Agency: GS1
Commercial Distribution End Date: January 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Tissue Resection Device

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?
62952	Hysteroscopic resection device	A sterile, hand-held, manual surgical instrument intended to be inserted through the working channel of a hysteroscope to cut and remove uterine lesions (e.g., polyps), and may in addition be used to obtain a mucosal biopsy. It consists of a distal cannula with a side-notch and internal oscillating cutting blade, a proximal handle/operating mechanism, and may include a suction port; it does not have a snare mechanism and is not an electrosurgical device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

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

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
Catheter Gauge: 9 French
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: d34b1026-cb95-4992-9f1b-20827a3c64ed
Public Version Date: July 20, 2022
Public Version Number: 2
DI Record Publish Date: January 24, 2020