ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142022975
• Version / Model: PGA
• Catalog Number: PU6094-B
• Company Name: Internacional Farmacéutica, S.A. de C.V.
• Labeler DUNS: 811313428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-18
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0f2cc870-1a6d-4205-9f49-19a7b9e0cc26
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT PGA SURGICAL SUTURE UNDYED USP 4-0 EP 1,5, 75 CM NEEDLE PU-60 PREMIUM STRAIGHT CUTTING 60 MM STRAIGHT PGA INCOLORO USP 4-0, 75 CM AGUJA PU-60 RECTA CORTANTE PREMIUM 60 MM RECTA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13908	Polyglycolic acid suture	A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07500142122972	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142022975	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040282	000

Device Sizes

Type	Value	Unit	Text
Length	60	Millimeter
Device Size Text, specify			RECTA
Device Size Text, specify			SUTURE UNDYED
Device Size Text, specify			ATRAMAT PGA
Device Size Text, specify			USP 4-0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 65 Percent (%) Relative Humidity