FDA.reportPublic FDA data

DELTA

Primary DI
07613327392715
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
70-76201
Catalog number
70-76201
Device description
DELTA WATER BATH 2.0
Published
2018-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRQUNIT, HEATING, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327392715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327392715076133273927157613327392715

GMDN Terms#

Term, Definition table
TermDefinition
Surgical water bath systemAn assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) water bath with temperature-regulating controls, a thermometer/thermostats, a timer, a sterilizable water holder (a pan or a tray), and a sterility cover that is placed over the bath to maintain the integrity of the sterile surgical field. The implants are submerged in sterile water or saline solution and typically heated to approximately 60-70? Celsius.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08
04546540274250NA64-0013264-001322017-01-11
04546540356758NA64-0024264-002422016-12-08
04546540356765NA64-0024364-002432016-12-08
04546540366467NA60-0950460-095042016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237626016HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237625545HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625552HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625569HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625576HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625583HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625590HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625606HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625613HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625620HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625637HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625644HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625651HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625668HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625675HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625460HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625477HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625484HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625491HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625507HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625514HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625521HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625538HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625439HydraThermDrive Devilbiss HealthcareIRQ2024-03-01
00092237625354HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625361HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625378HydraThermDrive Devilbiss HealthcareIRQ2024-02-29