CRY-AC Family Practice Package

Primary DI
00817434020074
Brand
CRY-AC Family Practice Package
Company
BRYMILL CORPORATION
Model
BRY-1001
Catalog number
BRY-1001
Device description
Hand Held Liquid Nitrogen Delivery System, Family Package
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193619000Cry-Ac®, Cry-Ac-3®, Cry-BabyBrymill Cryogenic Systems2020-03-25GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817434020074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817434020074008174340200748174340200740817434020074

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
860-875-2460brymill@brymill.com

Regulatory Flags#

DUNS number
041116500
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817434020067CRY-AC-3 Family Practice PackageBRY-1000BRY-10002016-10-18
00817434020081CRY-AC-3 Dermatology PackageBRY-1002BRY-10022016-10-18
008174340203331.0in x 20g Straight Spray108-20108-202016-12-16
00817434020463Cryocones3043042016-12-16
008174340205481.5x3mm Mini Probes214-15214-152016-12-19
008174340205552.5x5mm Mini Probes214-25214-252016-12-19
0081743402073919mm Domed Cervical Probes2062062016-12-19
0081743402074619mm Flat Cervical Probes2072072016-12-19
0081743402075325mm Domed Cervical Probes2082082016-12-19
0081743402076025mm Flat Cervical Probes2092092016-12-19
0081743402077719x5x5mm Cervical Probes2102102016-12-19
0081743402078425x5x5mm Cervical Probes2122122016-12-19
008174340207911cm Concave Probe2022022016-12-19
008174340208076x32mm Advanced Hemorrhoid Probe2132132016-12-19
00817434020012CRY-BABYB-400B-4002016-10-18
00817434020029CRY-ACB-700B-7002016-10-18
00817434020036CRY-AC-3B-800B-8002016-10-18
00817434020098CRY-AC Dermatology PackageBRY-1003BRY-10032016-10-18
00817434020104Withdrawal Device5025022016-12-14
00817434020111Withdrawl Tube5035032016-12-14