AccessGUDID - DEVICE: Active Sensor Module (00852184003472)

GUDID

Device Identifier (DI) Information

Brand Name: Active Sensor Module
Version or Model: 23-0007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Synapse Biomedical, Inc.

Primary DI Number: 00852184003472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138432070 *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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
47809	Percutaneous electrical stimulation lead external pulse generator cable, reusable	A noninvasive electrically-insulated wire intended to enable an electrical connection between an external pulse generator (EPG) of a [trial] implantable electrical stimulation system (e.g., intramuscular diaphragm/phrenic nerve or a spinal/peripheral nerve electrical stimulation system) and the proximal end of a percutaneously implanted lead, to permit the transmission of the electrical pulses and to create a return path to the EPG. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

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: 74c1dd76-b1ee-4343-b0b3-3f32c7d32636
Public Version Date: January 20, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 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
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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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