AccessGUDID - DEVICE: Silber (00827002152847)

GUDID

Device Identifier (DI) Information

Brand Name: Silber
Version or Model: G15284
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 020404
Company Name: COOK INCORPORATED

Primary DI Number: 00827002152847
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042823948 *Terms of Use

Device Description: Silber Aspiration Catheter

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?
47993	Epididymal fluid aspiration catheter	A flexible tube designed for the surgical aspiration of epididymal fluid during sperm extraction procedures such as microepididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), and during open testicular procedures. It is typically made of plastic materials [e.g., polyethylene (PE), polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane, or silicone] and is available in various lengths. The aspirate is processed for assisted reproductive technology (ART) procedures such as intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAP	CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE

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: 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: 631566c2-1363-427d-b03d-4333964d9847
Public Version Date: March 10, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2016

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

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