AccessGUDID - DEVICE: VL (04035479145293)

GUDID

Device Identifier (DI) Information

Brand Name: VL
Version or Model: 106157
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106157
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479145293
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":
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?
46226	Vein pick	A small surgical instrument that is used to open an incision in a vein typically for the introduction of an implantable pacing lead (the electrode tip) into the vein. It is typically a long, hand-held instrument that tapers to a blunt point at its distal end and is typically made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTB	permanent pacemaker Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980023	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
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: 6577db3a-f4f4-4c12-b0c0-d08ebb09dead
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04035479000462	5	04035479145293		In Commercial Distribution	case

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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