AccessGUDID - DEVICE: STERILE Mapping Probe (00852184003090)

GUDID

Device Identifier (DI) Information

Brand Name: STERILE Mapping Probe
Version or Model: 21-0001-99
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Synapse Biomedical, Inc.

Primary DI Number: 00852184003090
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):	Yes
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?
47811	Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return	A sterile implanted non-active wire (an indifferent anode), insulated with non-conductive material except at its electrode(s), used as part of an intramuscular diaphragm/phrenic nerve electrical stimulation system to create a return path for electrical current sent from an external pulse generator (EPG) to the phrenic nerve motor point in the diaphragm. The distal end of the electrode is placed against the internal tissue, and the proximal end protrudes percutaneously to connect to the external pulse generator (EPG) via a cable.	Active	true

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: Yes
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: 62eb2343-1c43-4d8a-a59d-b68792a39a42
Public Version Date: March 29, 2018
Public Version Number: 2
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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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