GEM

Basic Information

• Brand Name: GEM
• Primary DI: 03661522039441
• Version / Model: GEM1521
• Catalog Number: GEM1521
• Company Name: PETERS SURGICAL
• Labeler DUNS: 265741780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-31
• Public Version: 3
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 0f02f24d-c561-4970-8b67-cbc01ad192ca

Device Description

Titanium Hemostatic Clip - SuperFine MicroClips

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: Yes
• 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
FZP	Clip, Implantable	General, Plastic Surgery	878.4300	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
Previous	03661624005863	GS1
Package	13661522039448	GS1		30	In Commercial Distribution
Primary	03661522039441	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.