MicroCutter 30 Blue Reload

Basic Information

• Brand Name: MicroCutter 30 Blue Reload
• Primary DI: 11814900003209
• Version / Model: FG-025320
• Catalog Number: FG-025320
• Company Name: AESDEX, LLC
• Labeler DUNS: 081132841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 7
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 98dbe315-16d7-4efa-9d2e-c9327948fe95

Device Description

MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler

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
GDW	Staple, Implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35615	Surgical staple loading unit, non-cutting	A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	11814900003209	GS1
Unit of Use	01814900003202	GS1

Premarket Submissions

Submission Number	Supplement Number
K161137	000