AccessGUDID - DEVICE: Rocket (05055270964199)

GUDID

Device Identifier (DI) Information

Brand Name: Rocket
Version or Model: R57036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R57036
Company Name: ROCKET MEDICAL PLC

Primary DI Number: 05055270964199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544313588 *Terms of Use

Device Description: Rocket AmniocentesIs & CVS Sampling Set

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
56709	Chorionic villus sampling needle	A slender, sharply-pointed metal tube intended for transabdominal chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorionic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. It is introduced transcutaneously into the uterus, possibly using a guide cannula and under ultrasonographic guidance, and may include connectors, tubing and aspiration syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Atmospheric Pressure: exactly 101 KiloPascal
Storage Environment Temperature: between -5 and 30 Degrees Celsius
Storage Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between -5 and 40 Degrees Celsius
Handling Environment Humidity: between 1 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: exactly 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Length: 17.0 Centimeter
Outer Diameter: 1.473 Millimeter

Device Record Status

Public Device Record Key: f1359ec2-8f67-4536-aa36-4b1fec783ef8
Public Version Date: March 05, 2020
Public Version Number: 3
DI Record Publish Date: January 16, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05055270964205	10	05055270964199		In Commercial Distribution	Carton
05055270964212	8	05055270964205		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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +4401914196988
Email: gudid@rocketmedical.com

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