Disposable Distal Cap

Basic Information

• Brand Name: Disposable Distal Cap
• Primary DI: 06932503563482
• Version / Model: VC02134
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Labeler DUNS: 530269083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-30
• Public Version: 1
• Public Version Date: 2025-10-08
• Public Version Status: New
• Public Device Record Key: c717bb11-c5d9-4657-b444-309cb7277d77

Device Description

Standard type of Disposable Distal Cap, the maximum outer diameter of product is 13.4mm, the length from distal end of endoscopes is 10mm, the diameter of the side hole is 3mm, the total length is 20mm and the diameter of attaching endoscopic distal end is 10.9mm-11.8mm

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64014	Endoscope distal observation spacer, single-use	A short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap; it does not have anchoring capabilities (i.e., not an anchoring cuff). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16932503563489	GS1	BOX	10	In Commercial Distribution
Primary	06932503563482	GS1
Package	26932503563486	GS1	CASE	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243388	000

Device Sizes

Type	Value	Unit	Text
Length	10	Millimeter
Outer Diameter	13.4	Millimeter