AccessGUDID - DEVICE: Statcare spray (07540196002356)

GUDID

Device Identifier (DI) Information

Brand Name: Statcare spray
Version or Model: S500-6NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S500-6NA
Company Name: Scican Ltd

Primary DI Number: 07540196002356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204137145 *Terms of Use

Device Description: One step, pre-sterilization handpiece maintenance spray

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?
15772	Surgical instrument maintenance lubricant	A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: less than 122 Degrees Fahrenheit
Special Storage Condition, Specify: Protect from sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7cde9e4f-d5c9-4392-91c5-8038a850a3ce
Public Version Date: June 13, 2023
Public Version Number: 1
DI Record Publish Date: June 05, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17540196002353	6	07540196002356		In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18006677733
Email: tboyce@scican.com

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