AccessGUDID - DEVICE: ATRAMAT (07500142041808)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: SILK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C2633
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142041808
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 SILK SURGICAL SUTURE BLACK USP 3-0 EP 2, 75 CM NEEDLE C-26 REVERSE CUTTING 26 MM 1/2 CIRCLE

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?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAP	Suture, Nonabsorbable, Silk

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905287	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
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 26 Millimeter
Device Size Text, specify: UPS 3-0 EP 2

Device Record Status

Public Device Record Key: 9cb48c90-666f-4b75-a39a-7ec032b32ab3
Public Version Date: March 16, 2021
Public Version Number: 1
DI Record Publish Date: March 08, 2021