Standard Clamp, Disposable

Basic Information

• Brand Name: Standard Clamp, Disposable
• Primary DI: 00851677007003
• Version / Model: SCD25-1
• Catalog Number: SCD25-1
• Company Name: STANDARD BARIATRICS, INC
• Labeler DUNS: 091278068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-07
• Public Version: 5
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 27546f43-85ad-4d5a-a5f2-4bb11550d6aa

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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61839	Rigid endoscopic tissue manipulation forceps, single-use	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851677007003	GS1
Package	00851677007010	GS1		4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K181608	000