AccessGUDID - DEVICE: AlliedSil™ Sheeting (M724700071)

GUDID

Device Identifier (DI) Information

Brand Name: AlliedSil™ Sheeting
Version or Model: Size: 203.2mm x 152.4mm x 0.178mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-07
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724700071
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Silicone Sheeting Non-Reinforced

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45231	Silicone-sheet tissue reconstructive material, non-sterile	A non-sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy intended to be implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile). It may be cut into different sizes and shapes for various reconstructive or cosmetic plastic surgery applications that include repair of nasal septums, perforated eardrums, herniations, diaphragms, orbital floors, or congenital fissures of the abdominal wall.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MIB	Elastomer, Silicone Block

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971480	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de4688d8-427b-49a9-a445-c559ba53274e
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015