System Drape 610-870, H46222LS

GUDID 00841436104296

Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equipment

CIVCO MEDICAL INSTRUMENTS CO., INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID00841436104296
NIH Device Record Keyc0c29bdb-7b2f-47b8-bf8a-c35ab53d411a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem Drape
Version Model Number610-870, H46222LS
Catalog Number610-870, H46222LS
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch
Width81.3 Inch
Length91.4 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436104296 [Package]
Contains: 10841436104293
Package: [20 Units]
In Commercial Distribution
GS100841436109086 [Package]
Contains: 10841436104293
Package: [20 Units]
In Commercial Distribution
GS110841436104293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

[00841436104296]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-06
Device Publish Date2017-08-22

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00841436104296Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equ
00841436104029Sterile (11.9 tapered to 4.9 x 55.6cm) CIV-Flex™ cover for use with Mammotome EX and SenoRX En
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