FDA UDI In Commercial Distribution 🇺🇸 United States

Instrument Stringers

DI: 00849771013341 · Model: IS-7008 · KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Instrument Stringers
Primary DI
00849771013341
Version / Model
IS-7008
Company Name
KEY SURGICAL, INC.
Labeler DUNS
604056226
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-16
Public Version
3
Public Version Date
2021-09-08
Public Version Status
Update
Public Device Record Key
584e9c7b-b8d5-4ee5-b33d-d18bd3c5d826

Device Description

T-Bar Instrument Stringer, Surgical Stainless Steel, 8"

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
["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
MDM Instrument, Manual, Surgical, General Use

GMDN Terms

Code Name
64168 Sterilization stringer

Identifiers

Type ID
Primary 00849771013341

Customer Contacts