FDA UDI Not in Commercial Distribution 🇺🇸 United States

Key Surgical Needle Counters

DI: 00849771030539 · Model: NC-15-110 · KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Key Surgical Needle Counters
Primary DI
00849771030539
Version / Model
NC-15-110
Catalog Number
NC15110
Company Name
KEY SURGICAL, INC.
Labeler DUNS
604056226
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-09
Public Version
4
Public Version Date
2023-05-08
Public Version Status
Update
Public Device Record Key
d3ca3c3b-b75f-4e06-b4c1-b49d82b6932e
Distribution End Date
2023-05-05

Device Description

Needle Counters, Sterile, 15 Count, Magnetic with foam strips, Clear Lid, 50 per box

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GAB Needle, Suturing, Disposable

GMDN Terms

Code Name
61634 Sharp surgical instrument counting tray/pad, single-use

Identifiers

Type ID
Package 10849771030536
Primary 00849771030539

Customer Contacts