AccessGUDID - DEVICE: TC-PLUS / RT-PLUS (07611996024807)

GUDID

Device Identifier (DI) Information

Brand Name: TC-PLUS / RT-PLUS
Version or Model: 75005710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 75005710
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996024807
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 109903521 *Terms of Use

Device Description: TC/TC REV/RT/RT MOD PAT CLAMP BUSHING 35

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:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Implant handling forceps, scissors-like	A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Implant handling forceps, scissors-like

A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, surgical, instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 295b7a50-93a8-446a-93d7-939aad5dc408
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: November 25, 2015