FDA UDI In Commercial Distribution 🇺🇸 United States

Sterilization basket without lid

DI: G006DJ45611715 · Model: DJ-4561 · EFER ENDOSCOPY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sterilization basket without lid
Primary DI
G006DJ45611715
Version / Model
DJ-4561
Company Name
EFER ENDOSCOPY
Labeler DUNS
286097451
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-11-14
Public Version
1
Public Version Date
2023-11-22
Public Version Status
New
Public Device Record Key
479db249-2268-45dc-b0b6-ce621aa8d75d

Device Description

Basket for sterilization without lid and without silicone mat (External dimensions: 540 x 250 x 50 mm)

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EOQ Bronchoscope (Flexible Or Rigid)

GMDN Terms

Code Name
15074 Rigid optical bronchoscope

Identifiers

Type ID
Primary G006DJ45611715

Premarket Submissions

Submission Number Supplement Number
K854414 000