AccessGUDID - DEVICE: NA (ESOT031670)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Surgical suture nonabsorbable monofil Taper Point
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03167
Company Name: S & T AG

Primary DI Number: ESOT031670
Issuing Agency: HIBCC
Commercial Distribution End Date: March 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 481542926 *Terms of Use

Device Description: 5 V 33 11-0, Taper Point 11-0, Nylon black, 10 cm, sterile Box with 12 sutures

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):	Yes
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?
38000	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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Do not use if package is damaged
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not re-sterilise
Special Storage Condition, Specify: Protect from moisture
Special Storage Condition, Specify: Protect from direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: USP 11-0
Length: 10 Centimeter

Device Record Status

Public Device Record Key: 3fe57e74-d793-4af3-8846-a3497df2cf4c
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016