AccessGUDID - DEVICE: Prosthetic Silicone Materials (05060483013114)

GUDID

Device Identifier (DI) Information

Brand Name: Prosthetic Silicone Materials
Version or Model: AlSil Gum 80 Shore – 1kg
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL80A
Company Name: TECHNOVENT LIMITED

Primary DI Number: 05060483013114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225835156 *Terms of Use

Device Description: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials

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):	No
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?
64735	External limb prosthesis finishing component, custom-made	A custom-made cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) produced for a specific patient manually, or using computer-based anatomical imaging 3-D printing. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBI	Material, External Aesthetic Restoration, Used With Adhesive

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2764ea37-ac41-40c5-9811-54a9be5ded7e
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024