AccessGUDID - DEVICE: Saljet (20188151000002)

GUDID

Device Identifier (DI) Information

Brand Name: Saljet
Version or Model: Saljet 6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WINCHESTER LABORATORIES LLLP

Primary DI Number: 20188151000002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 038838914 *Terms of Use

Device Description: Saljet 6 is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into an outer shelf carton. six vials per carton.

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?
37298	Wound irrigation sterile saline	A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993969	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: d4b2e443-d52c-48a4-aee7-cfd33168cb2f
Public Version Date: August 07, 2019
Public Version Number: 1
DI Record Publish Date: July 30, 2019