FDA UDI In Commercial Distribution 🇺🇸 United States

NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE

DI: 00383790000284 · Model: 17GX1-1/4 · NIPRO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE
Primary DI
00383790000284
Version / Model
17GX1-1/4
Catalog Number
FS+173230BC-G
Company Name
NIPRO MEDICAL CORPORATION
Labeler DUNS
797372554
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-01
Public Version
3
Public Version Date
2018-12-20
Public Version Status
Update
Public Device Record Key
56f21143-b4fc-4530-98a8-3b992802ff40

Device Description

17Gx1-1/4" Fixed Hub 11" Tubing

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
No
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
No

Product Codes

Code Name
FIE Needle, fistula

GMDN Terms

Code Name
12741 Haemodialysis needle

Identifiers

Type ID
Package 10383790000281
Primary 00383790000284
Package 40383790000282