FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 00849771047636 · Model: Instrument Stringers · KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
00849771047636
Version / Model
Instrument Stringers
Catalog Number
IS35512
Company Name
KEY SURGICAL, INC.
Labeler DUNS
604056226
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-03-31
Public Version
1
Public Version Date
2023-04-10
Public Version Status
New
Public Device Record Key
f606add6-af7a-4803-a983-ab55ba5ea646

Device Description

Instrument Stringers, Surgical stainless steel, 12-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
Primary 00849771047636
Previous 00849771013150

Customer Contacts