AccessGUDID - DEVICE: Cook (00827002169081)

GUDID

Device Identifier (DI) Information

Brand Name: Cook
Version or Model: G16908
Commercial Distribution Status: In Commercial Distribution
Catalog Number: J-CVS-572700
Company Name: COOK INCORPORATED

Primary DI Number: 00827002169081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042823948 *Terms of Use

Device Description: Cook, Chorionic Villus 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":	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?
18105	Chorionic villus sampling catheter	A sterile flexible tube designed for transcervical chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorioinic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. The device usually includes a malleable, preshaped stylet, and is usually introduced under ultrasonographic guidance via the vagina/cervix. The suction for sampling is provided by an external syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLX	CATHETER, SAMPLING, CHORIONIC VILLUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P900007	001
P900007	004
P900007	005
P900007	006

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 in dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cb75a14a-6dff-4bd1-961e-57db83b7c9bd
Public Version Date: March 05, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2014

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(812)330-5494
Email: sharedservices@cookmedical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES