AccessGUDID - DEVICE: MANTIS™ Clip (00191506023591)

GUDID

Device Identifier (DI) Information

Brand Name: MANTIS™ Clip
Version or Model: M00521420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M00521420
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506023591
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Clip

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?
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PKL	Hemostatic metal clip for the GI tract

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
Length: 235 Centimeter
Device Size Text, specify: 2.8 mm Minimum Required Working Channel

Device Record Status

Public Device Record Key: 243b9480-3003-4d6a-8455-25249d28dd6a
Public Version Date: March 03, 2023
Public Version Number: 2
DI Record Publish Date: September 15, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
00191506023614	20	00191506023591	In Commercial Distribution
00191506023607	10	00191506023591	In Commercial Distribution
00191506023621	40	00191506023591	In Commercial Distribution