ATRAMAT

Basic Information

• Brand Name: ATRAMAT
• Primary DI: 07500142016523
• Version / Model: SEDA
• Catalog Number: SG3638
• 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: 2018-07-16
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 703abb35-7506-47f9-99b3-820c73fef1be
• Distribution End Date: 2040-12-31

Device Description

ATRAMAT SILK SURGICAL SUTURE BLACK USP 1 EP 4, 75 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE SEDA NEGRA USP 1, 75 CM AGUJA SG-36 AHUSADA GRUESA PREMIUM 36 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
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	878.5030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13910	Silk suture	A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07500142116520	GS1	DOZEN	12	In Commercial Distribution	2040-12-31
Primary	07500142016523	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905287	000

Device Sizes

Type	Value	Unit	Text
Length	36	Millimeter
Device Size Text, specify			1/2 CIRCLE
Device Size Text, specify			SUTURE BLACK
Device Size Text, specify			ATRAMAT SILK
Device Size Text, specify			USP 1

Storage Conditions

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