AccessGUDID - DEVICE: Enterra® II (00643169360686)

GUDID

Device Identifier (DI) Information

Brand Name: Enterra® II
Version or Model: 37800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169360686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: INS 37800 ENTERRA II NEUROSTIMULATOR

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:	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?
48001	Gastric electrical stimulation system	An assembly of devices designed to treat chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis through gastric electrical stimulation (GES) of the lower stomach (antrum). The assembly typically includes a battery-powered implantable pulse generator that produces the electrical stimuli delivered via implantable leads, and an external programmer that enables healthcare personnel to telemetrically modify the GES signal parameters of the pulse generator.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LNQ	intestinal 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
Handling Environment Temperature: between -30 and 135 Degrees Fahrenheit
Handling Environment Temperature: between -34 and 57 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55731b39-64f6-4c18-bc89-2e2dbcc812af
Public Version Date: October 16, 2023
Public Version Number: 4
DI Record Publish Date: October 03, 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: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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