FDA.reportPublic FDA data

DigniCap® Delta

Primary DI
00850036106319
Brand
DigniCap® Delta
Company
Dignitana AB
Model
800-1002
Catalog number
800-1002
Device description
Cooling Wrap, Standard Size, SPU, Qty 10
Published
2022-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00850036106319PrimaryGS10
00850036106203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036106319008500361063198500361063190850036106319
00850036106203008500361062038500361062030850036106203

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-375-8070info@dignitana.com

Regulatory Flags#

DUNS number
775901619
Device count
10
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
07350002100028DigniCapXS1Ref 132002016-11-01

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