AccessGUDID - DEVICE: TC-PLUS (07611996036596)

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Device Identifier (DI) Information

Brand Name: TC-PLUS
Version or Model: 75006069
Catalog Number: 75006069
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996036596
Issuing Agency: GS1
Device Count: 1

Device Description: TC PRIM/TC REV TIB INS TC CS ULTRAC 2/17

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic implant inserter/extractor	A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant inserter/extractor

A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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 Status

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

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

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

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DEVICE: TC-PLUS (07611996036596)