FDA UDI In Commercial Distribution 🇺🇸 United States

Steri-Cel Pre-Cut Sheet

DI: 00843356101263 · Model: SC4850 · CYGNUS MEDICAL L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25

Basic Information

Brand Name
Steri-Cel Pre-Cut Sheet
Primary DI
00843356101263
Version / Model
SC4850
Company Name
CYGNUS MEDICAL L.L.C.
Labeler DUNS
103169095
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2020-09-24
Public Version
2
Public Version Date
2023-02-20
Public Version Status
Update
Public Device Record Key
050dd946-a746-453a-af8c-ea77aacc4bb8

Device Description

Steri-Cel Pre-Cut Sheet 12 in. x 16 in. - 25 Sheets

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LRP Tray, Surgical

GMDN Terms

Code Name
63247 Surgical instrument guard, single-use

Identifiers

Type ID
Package 10843356101260
Primary 00843356101263
Unit of Use 30843356101264