FDA UDI In Commercial Distribution 🇺🇸 United States

Disposable Instruments

DI: 00845819000717 · Model: 4004 · OASIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Disposable Instruments
Primary DI
00845819000717
Version / Model
4004
Company Name
OASIS MEDICAL, INC.
Labeler DUNS
194121018
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-30
Public Version
1
Public Version Date
2023-07-10
Public Version Status
New
Public Device Record Key
bb8350b5-cbff-4fac-98b1-8fb91d4c86bc

Device Description

Retrobulbar Needle (Tri-Facet Point), 25g x 1-1/2" (0.5 x 38mm)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Radiation Sterilization

Product Codes

Code Name
GAA Needle, Aspiration And Injection, Disposable

GMDN Terms

Code Name
47610 Ophthalmic needle, single-use

Identifiers

Type ID
Package 10845819000714
Primary 00845819000717

Customer Contacts

Phone
9093055400