FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 00849771052210 · Model: Instrument Stringer · KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
00849771052210
Version / Model
Instrument Stringer
Catalog Number
IS55514
Company Name
KEY SURGICAL, INC.
Labeler DUNS
604056226
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-26
Public Version
1
Public Version Date
2023-02-03
Public Version Status
New
Public Device Record Key
f0a473f9-c18a-4247-bd96-076f37cbbd12

Device Description

U-Shaped Instrument Stringer, 14-inch x 5.5-inch

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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

GMDN Terms

Code Name
64168 Sterilization stringer

Identifiers

Type ID
Previous 00849771038290
Primary 00849771052210

Customer Contacts