AccessGUDID - DEVICE: Silicone Silo Bag (M746SSBWR030)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Silo Bag
Version or Model: SSB-WR03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SSB-WR03
Company Name: SPECIALTY SURGICAL PRODUCTS INC

Primary DI Number: M746SSBWR030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002112626 *Terms of Use

Device Description: Silicone Silo Bag, With Wire Ring For The Reduction of Abdominal Ventral Wall Defects

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61147	Negative-pressure wound therapy open-abdomen dressing	A sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973082	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
Width: 3.0 Centimeter

Device Record Status

Public Device Record Key: d7d8ffd0-15d1-42dd-b791-043dd7056c29
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2015