FDA.reportPublic FDA data

DigniCap

Primary DI
07350002100028
Brand
DigniCap
Company
Dignitana AB
Model
XS1
Catalog number
Ref 13200
Published
2016-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMCScalp Cooling System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMCScalp Cooling SystemGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350002100028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002100028073500021000287350002100028

GMDN Terms#

Term, Definition table
TermDefinition
Scalp cooling systemAn assembly of mains electricity (AC-powered) devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth200.2Millimeter
Height158.3Millimeter
Width168.6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4646163090info@dignitana.com

Regulatory Flags#

DUNS number
775901619
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850036106005DigniCap® Delta900-1001900-10012022-02-02
00850036106036DigniCap® Delta900-2001900-20012022-02-02
00850036106074DigniCap® Delta800-1001800-10012022-02-02
00850036106166DigniCap® Delta800-2001800-20012022-02-02
00850036106173DigniCap® Delta800-2002800-20022022-02-02
00850036106180DigniCap® Delta800-2003800-20032022-02-02
00850036106234DigniCap® Delta800-1104800-11042022-02-02
00850036106319DigniCap® Delta800-1002800-10022022-02-02
00850036106326DigniCap® Delta800-1003800-10032022-02-02
00850036106333DigniCap® Delta800-1004800-10042022-02-02
00850036106159DigniCap® Delta800-1201800-12012022-02-01
00850036106197DigniCap® Delta800-1102800-11022022-02-01
00850036106210DigniCap® Delta800-1103800-11032022-02-01
00850036106289DigniCap® Delta700-1004700-10042022-02-01
00850036106296DigniCap® Delta700-1005700-10052022-02-01
00850036106302DigniCap® Delta700-1006700-10062022-02-01
00850036106258DigniCap® Delta700-1001700-10012022-01-31
00850036106265DigniCap® Delta700-1002700-10022022-01-31
00850036106272DigniCap® Delta700-1003700-10032022-01-31
07350002100011Digni C3C3 - 115 VACRef 100332016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
89080300020134Eva Scalp Cooling System STEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020202Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020370Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-04
89080300020066Eva Scalp Cooling SystemSTEMTECH MEDICAL DEVICES PRIVATE LIMITEDPMC2026-05-01
00850051245239AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245246AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245253AMMACooler Heads Care, Inc.PMC2026-01-20
00850051245192AMMACooler Heads Care, Inc.PMC2025-12-22
00850051245116AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245123AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245130AMMACooler Heads Care, Inc.PMC2024-05-03
00850051245000AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245017AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245024AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245031AMMACooler Heads Care, Inc.PMC2023-10-24
00850051245048AMMACooler Heads Care, Inc.PMC2023-10-24
00851682007562Cooler HeadsPATHWAY, LLCPMC2022-11-07
B561PSCSKITL251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITLA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITM251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITMS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITS251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561PSCSKITSA251Paxman cap kitPAXMAN COOLERS LIMITEDPMC2022-03-18
B561CAPBATCH1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561CAPSIZINGPACKA1Paxman Cooling capPAXMAN COOLERS LIMITEDPMC2022-03-07
B561COOLANTBATCH1PSCS CoolantPAXMAN COOLERS LIMITEDPMC2022-03-07
B561PSCSCAPMEDSML0Paxman Cooling CapPAXMAN COOLERS LIMITEDPMC2022-03-07
00850036106005DigniCap® DeltaDignitana ABPMC2022-02-02
00850036106036DigniCap® DeltaDignitana ABPMC2022-02-02