AccessGUDID - DEVICE: Cinch™ (05414734400688)

GUDID

Device Identifier (DI) Information

Brand Name: Cinch™
Version or Model: 1194
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1194
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734400688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: No description.

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?
42410	Electrical cable/lead holder	A device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
GZB	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081208	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
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 98ee35ef-9bfc-4c43-9c49-805d79e4c223
Public Version Date: May 03, 2023
Public Version Number: 4
DI Record Publish Date: April 15, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
15414734400685	5	05414734400688		In Commercial Distribution

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(855)478-5833
Email: customerservice@sjm.com

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

FDA TOOLS & RESOURCES