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

GUDID

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

Primary DI Number: 07611996024807
Issuing Agency: GS1
Device Count: 1

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

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 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 during implantation; it is not intended for use on soft tissues. 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.

Product Code	Product Code Name
FZX	Guide, surgical, instrument

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: November 25, 2015
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)238-7538
Email: GUDID@SMITH-NEPHEW.COM