ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142014000
• Version / Model: POLIPROPILENO
• Catalog Number: P-PE1365
• 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: 2016-09-28
• Public Version: 7
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 9b602106-b691-4124-be18-91b28a0e5c15
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 5-0 EP 1, 45 CM NEEDLE P-PE-13 SUPRA-SHARP REVERSE CUTTING 13 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 5-0, 45 CM AGUJA P-PE-13 REVERSO CORTANTE SUPRA-SHARP 13 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
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	07500142114007	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142014000	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911189	000

Device Sizes

Type	Value	Unit	Text
Length	13	Millimeter
Device Size Text, specify			3/8 CIRCLE
Device Size Text, specify			SUTURE BLUE
Device Size Text, specify			ATRAMAT POLYPROPYLENE
Device Size Text, specify			USP 5-0

Storage Conditions

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