ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142004766
• Version / Model: PGA
• Catalog Number: F1395
• 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: 2018-07-06
• Public Version: 1
• Public Version Date: 2018-08-06
• Public Version Status: New
• Public Device Record Key: 2880394c-8aae-481d-b8bf-a27ec8c6b2f1
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT PGA SURGICAL SUTURE VIOLET USP 5-0 EP 1, 70 CM NEEDLE F-13 FINE TAPER POINT 13 MM 1/2 CIRCLE PGA VIOLETA USP 5-0, 70 CM AGUJA F-13 AHUSADA FINA 13 MM 1/2 CIRCULO

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: Yes
• 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	07500142104763	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142004766	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040282	000

Device Sizes

Type	Value	Unit	Text
Length	13	Millimeter
Device Size Text, specify			1/2 CIRCLE
Device Size Text, specify			SUTURE VIOLET
Device Size Text, specify			ATRAMAT PGA
Device Size Text, specify			USP 5-0

Storage Conditions

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