AccessGUDID - DEVICE: RAM® COR-SUTURE® QUICK LOAD® (00850200006827)

GUDID

Device Identifier (DI) Information

Brand Name: RAM® COR-SUTURE® QUICK LOAD®
Version or Model: 022677
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 022677
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 5MM, PLEDGETED 2-0 POLYESTER, GREEN (3) and WHITE (3), NON-ABSORBABLE, 38"

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
13906	Polyester suture, non-bioabsorbable, multifilament	A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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
GAS	Suture, nonabsorbable, synthetic, polyester

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160529	000
K203081	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 38 Inch

Device Record Status

Public Device Record Key: 5ce1b67c-79da-4cce-8d4e-815ddb0d637d
Public Version Date: November 07, 2022
Public Version Number: 6
DI Record Publish Date: March 13, 2020