AccessGUDID - DEVICE: ATRAMAT (07500142005626)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: NYLON
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PE1944-N
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142005626
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2040
Device Count: 1
Labeler D-U-N-S® Number*: 811313428 *Terms of Use

Device Description: ATRAMAT NYLON SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE NYLON NEGRO USP 4-0, 45 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 19 MM 3/8 CIRCULO

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

GMDN Preferred Term Name

GMDN Definition

Nylon suture, non-bioabsorbable, monofilament

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

FDA Product Code

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Product Code	Product Code Name
GAR	Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905286	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
Length: 19 Millimeter
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: SUTURE BLACK
Device Size Text, specify: ATRAMAT NYLON
Device Size Text, specify: USP 4-0

Device Record Status

Public Device Record Key: 5202753c-387e-4bb2-8d59-63e83ebbea42
Public Version Date: February 07, 2019
Public Version Number: 6
DI Record Publish Date: September 27, 2016