FDA.reportPublic FDA data

NA

Primary DI
10887587057224
Brand
NA
Company
Synthes GmbH
Model
530.514
Catalog number
530514
Device description
WATER BATH STERILITY COVER
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTQBATH, INCUBATORS/WATER, ALL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTQBath, Incubators/Water, AllMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819715547Direct MarkingGS10
10887587057224PrimaryGS10
H9805305140SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819715547076118197155477611819715547
1088758705722410887587057224

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664816002322LW Scientific, IncLW SCIENTIFIC, INC.JTQ2026-02-19
00664816005699LW Scientific, Inc.LW SCIENTIFIC, INC.JTQ2026-02-16
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06976301910369YingtaiChangsha Yingtai Instrument Co., LtdJTQ2025-03-01
06976301910383YingtaiChangsha Yingtai Instrument Co., LtdJTQ2025-03-01
06976301910390YingtaiChangsha Yingtai Instrument Co., LtdJTQ2025-03-01
06976301910406YingtaiChangsha Yingtai Instrument Co., LtdJTQ2025-03-01
06976301910413YingtaiChangsha Yingtai Instrument Co., LtdJTQ2025-03-01
58059796363933WASPLab®COPAN WASP SRLJTQ2024-06-04
58059796363940WASPLab® ConveyorCOPAN WASP SRLJTQ2024-06-04
58059796363957WASPLab® Single IncubatorCOPAN WASP SRLJTQ2024-06-04
58059796363964WASPLab® Double IncubatorCOPAN WASP SRLJTQ2024-06-04
06974440221018Haier BiomedicalQingdao Haier Biomedical Technology Co.,Ltd.JTQ2024-05-23
06974440221025Haier BiomedicalQingdao Haier Biomedical Technology Co.,Ltd.JTQ2024-05-23
06974440221032Haier BiomedicalQingdao Haier Biomedical Technology Co.,Ltd.JTQ2024-05-23
00382904469481BD Kiestra™ ReadABD Kiestra B.V.JTQ2023-09-14
D248429040CATALINA WATER BATH 2000 110V Serial Number:HAGER WORLDWIDE, INC.JTQ2023-08-10
10889950076139HuFriedyGroupHU-FRIEDY MFG. CO., LLCJTQ2023-06-09
00850229007072StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJTQ2023-06-05
00850229007089StatFax AWARENESS TECHNOLOGY, INCORPORATEDJTQ2023-06-05
00613647024386FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024393FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024409FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024416FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024508FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024515FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21
00613647024522FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JTQ2022-09-21