FDA UDI In Commercial Distribution 🇺🇸 United States

ORTHOMED

DI: B803420825L0 · Model: OM 42-0825L · ORTHO-MED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ORTHOMED
Primary DI
B803420825L0
Version / Model
OM 42-0825L
Company Name
ORTHO-MED, INC.
Labeler DUNS
086618626
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-09-27
Public Version
1
Public Version Date
2023-10-05
Public Version Status
New
Public Device Record Key
34d91f0c-a9d4-414a-b4ce-4194fb2cb32c

Device Description

FRAZIER SUCTION TUBE 8 FR 9" OAL 130MM WL 30 DEG

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
No
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
GEA Cannula, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
38749 Surgical/emergency suction cannula, non-illuminating, reusable

Identifiers

Type ID
Primary B803420825L0