FDA UDI Not in Commercial Distribution 🇺🇸 United States

ESTEEM SYN POST OP KIT STER

DI: 00768455105328 · Model: 409345 · CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5

Basic Information

Brand Name
ESTEEM SYN POST OP KIT STER
Primary DI
00768455105328
Version / Model
409345
Catalog Number
409345
Company Name
CONVATEC, PURCHASING DEPARTMENT
Labeler DUNS
809784593
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2016-09-01
Public Version
5
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
7577d1a1-657b-4f8f-84ea-2c5de8b30577
Distribution End Date
2022-05-20

Device Description

ESTEEM SYN POST OP KIT STER

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
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
FON Bag, Drainage, With Adhesive, Ostomy

GMDN Terms

Code Name
31076 Multiple-piece intestinal ostomy bag, open-ended

Identifiers

Type ID
Primary 00768455105328
Unit of Use 08768455105320
Package 10768455105325

Device Sizes

Type Value Unit Text
Device Size Text, specify 89 mm diameter