AccessGUDID - DEVICE: Scrip Hessco (00812433020001)

GUDID

Device Identifier (DI) Information

Brand Name: Scrip Hessco
Version or Model: 663 0061
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scriphessco

Primary DI Number: 00812433020001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054152269 *Terms of Use

Device Description: Scrip Hessco Ultrasound Gel Gallon

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?
64352	Ultrasound contrast medium, transuterine administration	A substance/formulation (e.g., solution, gel, foam) intended to be administered into the female reproductive tract, via the vagina/uterus, to enhance diagnostic ultrasound images, typically for the evaluation of the uterine cavity and/or fallopian tube patency. It may include devices for substance preparation/mixing [e.g., syringe, connector], however invasive devices for substance administration (e.g., catheter, speculum) are not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media,Coupling,Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955246	000

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
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9229f3de-8582-40d4-b94d-8fedc52f08c1
Public Version Date: October 24, 2019
Public Version Number: 1
DI Record Publish Date: October 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 6307717459
Email: lrogus@scripco.com

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