AccessGUDID - DEVICE: EFH-6F-W (04035479157821)

GUDID

Device Identifier (DI) Information

Brand Name: EFH-6F-W
Version or Model: 433306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 433306
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479157821
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *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?
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
DTB	Permanent Pacemaker Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950037	181

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
Storage Environment Temperature: between 41 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b558405-c6fd-474d-8c4b-ac156425c98e
Public Version Date: November 25, 2024
Public Version Number: 5
DI Record Publish Date: November 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04035479158231	5	04035479157821		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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)345-0374
Email: jon.brumbaugh@biotronik.com

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