ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142080685
• Version / Model: ACERO
• Catalog Number: SG26109X4
• 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: 2018-07-31
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 820d36f8-5b52-43a0-80b5-120cdc34ef46
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT STAINLESS STEEL SURGICAL SUTURE USP 2 EP 5, 4 X 45 CM NEEDLE SG-26 PREMIUM HEAVY TAPER POINT 26 MM 1/2 CIRCLE ACERO INOXIDABLE USP 2, 4 X 45 CM AGUJA SG-26 AHUSADA GRUESA PREMIUM 26 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
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	878.4495	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15971	Metallic suture, monofilament	A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07500142180682	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142080685	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K913185	000

Device Sizes

Type	Value	Unit	Text
Length	26	Millimeter
Device Size Text, specify			1/2 CIRCLE
Device Size Text, specify			SURGICAL SUTURE
Device Size Text, specify			ATRAMAT STAINLESS STEEL
Device Size Text, specify			USP 2

Storage Conditions

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