Sharpoint Plus

Basic Information

• Brand Name: Sharpoint Plus
• Primary DI: 00848782009602
• Version / Model: J8695N
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Labeler DUNS: 812762226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-18
• Public Version: 8
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: d648c7b0-4562-47db-8abd-0c589537bcf1
• Distribution End Date: 2015-09-23

Device Description

Ds14 6-0 Bl Ppn 18"/45 Cm

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: 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: 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
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	878.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10848782009609	GS1		12	Not in Commercial Distribution	2015-09-23
Primary	00848782009602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131224	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6-0