FDA UDI In Commercial Distribution 🇺🇸 United States

De Soutter Medical

DI: 05051471153257 · Model: S25-381 · 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
05051471153257
Version / Model
S25-381
Catalog Number
S25-381
Company Name
DE SOUTTER MEDICAL LIMITED
Labeler DUNS
458064144
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-24
Public Version
1
Public Version Date
2022-12-02
Public Version Status
New
Public Device Record Key
a8e212cd-007c-4a2f-b824-19aa59585d6a

Device Description

KEEL BLADE - AESCULAP CEMENTLESS 14 x 15 x 2.93mm

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
45493 Surgical saw blade, reciprocating, single-use

Identifiers

Type ID
Package 15051471153254
Primary 05051471153257