ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142053344
• Version / Model: PGLA90
• Catalog Number: P-PE19304-45B
• 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: 2016-10-14
• Public Version: 7
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: cd0d8339-9f3b-4292-a428-7d6527ce2db2
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-19 SUPRA-SHARP REVERSE CUTTING 19 MM 3/8 CIRCLE PGLA90 INCOLORO USP 4-0, 45 CM AGUJA P-PE-19 REVERSO CORTANTE SUPRA-SHARP 19 MM 3/8 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: 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
17471	Polyester suture, bioabsorbable, multifilament, non-antimicrobial	A multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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	07500142153341	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142053344	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072859	000

Device Sizes

Type	Value	Unit	Text
Length	19	Millimeter
Device Size Text, specify			3/8 CIRCLE
Device Size Text, specify			SUTURE UNDYED
Device Size Text, specify			ATRAMAT PGLA90
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