AccessGUDID - DEVICE: SSPC3 Delivery Catheter (00810024671830)

GUDID

Device Identifier (DI) Information

Brand Name: SSPC3 Delivery Catheter
Version or Model: 9183
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CENTERPOINT SYSTEMS LLC

Primary DI Number: 00810024671830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117126091 *Terms of Use

Device Description: Catheter and Dilator

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61501	Pacing/defibrillation lead delivery catheter	A sterile, non-steerable, thin flexible tube intended to be introduced percutaneously into the cardiac anatomy (e.g., coronary sinus) to provide a conduit for the delivery of a cardiac pacing and/or defibrillation lead (not included). It may include additional synergistic catheters and is intended to be introduced through a separate catheter introducer sheath, which may be included along with additional devices dedicated to catheter introduction/function. It does not contain electrodes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190475	000

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: Keep dry
Special Storage Condition, Specify: Do not store in direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Maximum Compatible Guidewire Outside Diameter: 0.035"
Device Size Text, specify: Inner Diameter: 6.5F
Device Size Text, specify: Outer Diameter: 8F
Catheter Working Length: 40 Centimeter

Device Record Status

Public Device Record Key: 6c68e41e-77dd-4f6e-808f-7b7300b0dcdf
Public Version Date: May 28, 2020
Public Version Number: 2
DI Record Publish Date: August 21, 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 877-848-0828
Email: info@centerpoint-systems.com

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