FDA UDI In Commercial Distribution 🇺🇸 United States

2.4mm Long Shaft PerCryo™ Cryoprobe

DI: 00810563020779 · Model: DP35-0943-206 · VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
2.4mm Long Shaft PerCryo™ Cryoprobe
Primary DI
00810563020779
Version / Model
DP35-0943-206
Catalog Number
PCS-24L
Company Name
VARIAN MEDICAL SYSTEMS, INC.
Labeler DUNS
009120817
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-02-18
Public Version
1
Public Version Date
2022-02-28
Public Version Status
New
Public Device Record Key
3730771b-3548-4a50-a483-e98018d656a5

Device Description

Right angle 2.4mm cryoprobe, long shaft for use with Cryocare systems (Lead-Free)

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
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEH UNIT, CRYOSURGICAL, ACCESSORIES

GMDN Terms

Code Name
45150 Ophthalmic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 00810563020779

Premarket Submissions

Submission Number Supplement Number
K153489 000