FDA UDI Not in Commercial Distribution 🇺🇸 United States

De Soutter Medical

DI: 05051471155947 · Model: S08-012 · DE SOUTTER MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
De Soutter Medical
Primary DI
05051471155947
Version / Model
S08-012
Catalog Number
S08-012
Company Name
DE SOUTTER MEDICAL LIMITED
Labeler DUNS
458064144
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-22
Public Version
2
Public Version Date
2024-01-22
Public Version Status
Update
Public Device Record Key
3e82e2d1-c9d6-407f-a17e-a0aca137115a
Distribution End Date
2023-07-01

Device Description

PROCEDURE PACK

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEY Motor, Surgical Instrument, Ac-Powered

GMDN Terms

Code Name
43376 Surgical saw blade, sagittal, single-use

Identifiers

Type ID
Package 15051471155944
Primary 05051471155947