AccessGUDID - DEVICE: ATRAMAT (07500142025648)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: POLIPROPILENO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P-PE1166
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142025648
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 POLYPROPYLENE SURGICAL SUTURE BLUE USP 6-0 EP 0.7, 45 CM NEEDLE P-PE-11 SUPRA-SHARP REVERSE CUTTING 11 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 6-0, 45 CM AGUJA P-PE-11 REVERSO CORTANTE SUPRA-SHARP 11 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":	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911189	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

[?]

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

[?]

Size Type Text
Length: 11 Millimeter
Device Size Text, specify: ATRAMAT POLYPROPYLENE
Device Size Text, specify: USP 6-0
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: SUTURE BLUE

Device Record Status

Public Device Record Key: 0b00fda6-b8cc-4aa8-8a72-f7a6a834a037
Public Version Date: June 02, 2023
Public Version Number: 7
DI Record Publish Date: September 28, 2016