AccessGUDID - DEVICE: NA (05415067037275)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: DS2A088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS2A088
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067037275
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Suture Sleeve

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
46225	Implantable electrical stimulation lead suture sleeve	A small device with a hollow centre that functions as a channel for an implantable electrical stimulation lead (e.g., pacing lead, defibrillation lead, neurostimulation lead) intended to be positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the electrical stimulator, pacemaker or defibrillator system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NVN	Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960013	118

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 Temperature: between -5 and 50 Degrees Celsius
Special Storage Condition, Specify: Storage excursions permitted from 59°- 86° F (15°- 30°C).
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 6.0000 French

Device Record Status

Public Device Record Key: 6b50a2fe-f4e2-48f5-84b8-4eb58ea3a12d
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: January 07, 2022

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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