AccessGUDID - DEVICE: SUTURE LOOP HI-FI (10653405002086)

GUDID

Device Identifier (DI) Information

Brand Name: SUTURE LOOP HI-FI
Version or Model: HL201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HL201
Company Name: Conmed Corporation

Primary DI Number: 10653405002086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SutureLoop Hi-Fi Suture 20 inch Loop (5 Metric) White/Blue, Hi-Fi Polyblend Suture, Curved Needle

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?
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100006	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
Device Size Text, specify: .5 X 48
Device Size Text, specify: METRIC
Device Size Text, specify: LOOP

Device Record Status

Public Device Record Key: df7406ee-d97b-4095-ac0e-ca183d287c32
Public Version Date: December 04, 2020
Public Version Number: 6
DI Record Publish Date: October 24, 2015