Resolution Clip

Basic Information

• Brand Name: Resolution Clip
• Primary DI: 08714729504795
• Version / Model: M00522610
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: e62efd6d-3ae4-4f71-9543-98161d8806e2

Device Description

Clipping Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKL	Hemostatic metal clip for the GI tract	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08714729504818	GS1		20	In Commercial Distribution
Primary	08714729504795	GS1
Package	08714729504801	GS1		10	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			235 cm Effective Length
Device Size Text, specify			2.8 mm Diameter