FDA UDI In Commercial Distribution 🇺🇸 United States

Scheker DRUJ

DI: B013MITDRUJ1000 · Model: MITDRUJ-100 · APTIS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Scheker DRUJ
Primary DI
B013MITDRUJ1000
Version / Model
MITDRUJ-100
Catalog Number
MITDRUJ-100
Company Name
APTIS MEDICAL, LLC
Labeler DUNS
780455338
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-11-26
Public Version
2
Public Version Date
2024-08-30
Public Version Status
Update
Public Device Record Key
596e1bc8-7276-4f69-80f4-077d9c49d6f9

Device Description

Metal Instrument Tray, Distal Radioulnar Joint

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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LRP Tray, Surgical

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary B013MITDRUJ1000