FDA UDI Not in Commercial Distribution 🇺🇸 United States

Enterra® II

DI: 00763000449704 · Model: 37800 · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Enterra® II
Primary DI
00763000449704
Version / Model
37800
Company Name
MEDTRONIC, INC.
Labeler DUNS
796986144
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-28
Public Version
3
Public Version Date
2025-10-09
Public Version Status
Update
Public Device Record Key
a4a3a6a5-90b7-4b08-a6d4-aa1da28dc44d
Distribution End Date
2025-10-07

Device Description

INS 37800 ENTERRA II EMAN US

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LNQ intestinal Stimulator

GMDN Terms

Code Name
48001 Gastric electrical stimulation system

Identifiers

Type ID
Primary 00763000449704

Customer Contacts