AccessGUDID - DEVICE: TW (04035479145286)

GUDID

Device Identifier (DI) Information

Brand Name: TW
Version or Model: 108984
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 108984
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479145286
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?
46223	Pacing/defibrillation lead setscrew	A sterile device designed to secure the attached pacing lead terminal(s) in the header connector (connection socket) of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure. It is typically made of high-grade stainless steel or titanium (Ti). The device is typically available in a set of graduated sizes. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DXY	implantable pacemaker Pulse-generator

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: 00a10bae-d69d-41a7-ba56-7fc502cdbe2e
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
04035479000875	5	04035479145286		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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