FDA UDI In Commercial Distribution 🇺🇸 United States

Monty 3D TT Plus

DI: B8961123120 · Model: 11.2312 · REHAdapt Engineering GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Monty 3D TT Plus
Primary DI
B8961123120
Version / Model
11.2312
Company Name
REHAdapt Engineering GmbH & Co. KG
Labeler DUNS
340146982
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-26
Public Version
1
Public Version Date
2022-08-03
Public Version Status
New
Public Device Record Key
9fc872fe-734e-41b3-8cfd-f0c6c1442310

Device Description

M3D two-tube wheelchair mount with long range. RotLok base with swivel function and UDS-DC. Tube lengths: 500 x 500 mm (20 x 20"). Additional 300 mm tube included. Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included.

Device Characteristics

Single Use
No
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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KNO Accessories, Wheelchair

GMDN Terms

Code Name
61434 Portable active medical device mount

Identifiers

Type ID
Primary B8961123120