AccessGUDID - DEVICE: TetraSens (07350012440169)

GUDID

Device Identifier (DI) Information

Brand Name: TetraSens
Version or Model: SEN 2012 TetraSens
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SEN 2012
Company Name: Senzime AB (Publ.)

Primary DI Number: 07350012440169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559976316 *Terms of Use

Device Description: TetraSens with EZconnect

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35722	Block-monitoring peripheral nerve electrical stimulation system	An assembly of battery-powered devices designed to apply electrical stimuli to a peripheral nerve (e.g., the ulnar or lower extremity nerve) to assess the adequacy of neuromuscular block during surgery, and its reversal during the recovery period. The system typically uses four kinds of stimulation: twitch, train-of-four, tetanic, and double burst. It typically includes conventional electrocardiographic electrodes and/or bipolar surface electrodes (ball electrodes), and a pulse generator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOI	Stimulator, Nerve, Peripheral, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b227d4ac-2b8f-4371-b2c1-019c85480034
Public Version Date: July 24, 2024
Public Version Number: 2
DI Record Publish Date: April 26, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07350012440176	20	07350012440169		In Commercial Distribution	Box

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: 800-213-1324
Email: info.us@senzime.com

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