Digni C3 Ref 10033

GUDID 07350002100011

Dignitana AB

Scalp cooling system
Primary Device ID07350002100011
NIH Device Record Key539e0b53-f17f-4961-a941-ddbbd621dfa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigni C3
Version Model NumberC3 - 115 VAC
Catalog NumberRef 10033
Company DUNS775901619
Company NameDignitana AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com
Phone4646163090
Emailinfo@dignitana.com

Device Dimensions

Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter
Weight75 Kilogram
Depth65 Centimeter
Width58 Centimeter
Height110 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107350002100011 [Primary]

FDA Product Code

PMCScalp Cooling System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-01

Devices Manufactured by Dignitana AB

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00850036106036 - DigniCap® Delta2022-02-10 Connection Kit, US, DCD-01
00850036106074 - DigniCap® Delta2022-02-10 1-ct Single-Use DeltaCard, DCD
00850036106166 - DigniCap® Delta2022-02-10 DeltaKit 1 (Mesh bag includes Cooling Wrap, Thermal Cap, Chin Strap, Wet Brush, Spray Bottle, Headband, & Patient Guide)
00850036106173 - DigniCap® Delta2022-02-10 DeltaKit 2 (Mesh bag includes Cooling Wrap, Chin Strap, Wet Brush, Spray Bottle, Headband, & Patient Guide)
00850036106180 - DigniCap® Delta2022-02-10 DeltaKit 3 - DeltaKit 3 (Mesh bag includes Cooling Wrap, Chin Strap, Headband, & Patient Guide)
00850036106234 - DigniCap® Delta2022-02-10 Thermal Cap, Universal Size, SPU, 1-ct
00850036106319 - DigniCap® Delta2022-02-10 Cooling Wrap, Standard Size, SPU, Qty 10

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