FDA UDI In Commercial Distribution 🇺🇸 United States

SR-3053

DI: B824SR3053S1 · Model: S · RED OAK INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SR-3053
Primary DI
B824SR3053S1
Version / Model
S
Catalog Number
SR-3053-S
Company Name
RED OAK INSTRUMENTS, LLC
Labeler DUNS
025026245
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-10
Public Version
1
Public Version Date
2020-01-20
Public Version Status
New
Public Device Record Key
50454c89-55c5-4079-8ff8-ce3cb042d6e6

Device Description

Fine motor control measurements

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LBB Dynamometer, Ac-Powered

GMDN Terms

Code Name
33785 Hand dynamometer/pinchmeter, electronic

Identifiers

Type ID
Primary B824SR3053S1

Customer Contacts

Phone
9999999999

Premarket Submissions

Submission Number Supplement Number
K012492 000