AccessGUDID - DEVICE: UNIFY Chromic Gut Surgical Sutures (00814639021318)

GUDID

Device Identifier (DI) Information

Brand Name: UNIFY Chromic Gut Surgical Sutures
Version or Model: XL-C227T36
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APPLIED DENTAL, INC.

Primary DI Number: 00814639021318
Issuing Agency: GS1
Commercial Distribution End Date: May 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 017524666 *Terms of Use

Device Description: Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27"

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32eada71-093a-4d0d-aad6-34a74cd01a8d
Public Version Date: February 05, 2021
Public Version Number: 6
DI Record Publish Date: August 21, 2015