FDA UDI Not in Commercial Distribution 🇺🇸 United States

Key Surgical Trays

DI: 00849771032267 · Model: SB-4210 · KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Key Surgical Trays
Primary DI
00849771032267
Version / Model
SB-4210
Company Name
KEY SURGICAL, INC.
Labeler DUNS
604056226
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-21
Public Version
6
Public Version Date
2023-01-24
Public Version Status
Update
Public Device Record Key
56f62836-4c51-4c8f-971d-fd769ae498ab
Distribution End Date
2023-01-18

Device Description

Instrument Trays and Covers, Endoscope Basket with Lid, 460 x 80 x 52mm

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

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

Product Codes

Code Name
LRP Tray, Surgical

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00849771032267

Customer Contacts