AccessGUDID - DEVICE: Technical Products (B0515010S680)

GUDID

Device Identifier (DI) Information

Brand Name: Technical Products
Version or Model: 501-0S68
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECHNICAL PRODUCTS INC

Primary DI Number: B0515010S680
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040679649 *Terms of Use

Device Description: silicone sheet sterile

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":	Yes
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
Silicone-sheet tissue reconstructive material, sterile	A sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive otorhinolaryngology/head and neck surgery applications (e.g., repair of nasal septums, perforated eardrums).

GMDN Preferred Term Name

GMDN Definition

Silicone-sheet tissue reconstructive material, sterile

A sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive otorhinolaryngology/head and neck surgery applications (e.g., repair of nasal septums, perforated eardrums).

FDA Product Code

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Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971472	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: .007"x6"x8" Reinforced

Device Record Status

Public Device Record Key: 3c6ab02b-204d-4fe2-8437-b4ac2731de5b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016