AccessGUDID - DEVICE: Silverstream OTC (07290019690108)

GUDID

Device Identifier (DI) Information

Brand Name: Silverstream OTC
Version or Model: SS-1000-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FBS-01-1-OSS-1000-01
Company Name: SilverStream Medical Ltd.

Primary DI Number: 07290019690108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533346805 *Terms of Use

Device Description: SilverStream OTC 250ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level.

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):	No
Over the Counter (OTC):	Yes
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?
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093227	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
Special Storage Condition, Specify: Store at room temp
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 250 Milliliter

Device Record Status

Public Device Record Key: 4ee6b744-92be-4fbf-b2f2-578adc27b336
Public Version Date: May 27, 2024
Public Version Number: 1
DI Record Publish Date: May 19, 2024