FDA.reportPublic FDA data

RESORB X

Primary DI
00888118096982
Brand
RESORB X
Company
KLS-Martin L.P.
Model
52-400-98-04
Published
2020-06-19
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

Contact Domains#

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
00888118096982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118096982008881180969828881180969820888118096982

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(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

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
00092237626009HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237626016HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237625545HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625552HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625569HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625576HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625583HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625590HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625606HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625613HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625620HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625637HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625644HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625651HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625668HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625675HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625460HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625477HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625484HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625491HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625507HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625514HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625521HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625538HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625439HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-01
00092237625354HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625361HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625378HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29