FDA.reportPublic FDA data

NA

Primary DI
10886982239914
Brand
NA
Company
Synthes GmbH
Model
530.413
Catalog number
530413
Device description
CABLE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM
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
LXCMONITOR, PRESSURE, INTRACOMPARTMENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031555000SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEMSynthes (Usa)2003-07-08LXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982239914PrimaryGS10
H6795304130SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223991410886982239914

GMDN Terms#

Term, Definition table
TermDefinition
Compartmental-pressure monitoring system, reusableAn assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., transducing probe, extension cable). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a reusable device.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14
10705034800011ChronOS710.039.99S71003999S2015-09-14
10705034800059ChronOS710.921.99S71092199S2015-09-14
10705034800066ChronOS710.922.99S71092299S2015-09-14
10705034800073ChronOS710.923.99S71092399S2015-09-14
10705034800080ChronOS710.924.99S71092499S2015-09-14
10705034800097ChronOS710.925.99S71092599S2015-09-14
10705034800103ChronOS710.926.99S71092699S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G247CPMX10CPMX1Compremium AGLXC2025-05-19
07540162030093MY01 Mobile ApplicationMY01 IncLXC2025-04-29
10840199544223Rhoton Spetzler Type SetKOROS U.S.A., INC.LXC2022-12-31
10810063754652Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754669Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754676Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754683Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754690Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754706Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754713Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754720Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754737Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754744Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754751Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754768Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754775Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754782Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754799Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754812Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754829Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
10810063754843Safco Nitrilex Prevail GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754655Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754662Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754686Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754693Safco Nitrilex Black GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754709Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754747Safco Nitrilex UltraSoft GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754761Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
00810063754778Safco Nitrilex GlovesSAFCO DENTAL SUPPLY CO.LXC2022-11-29
D72310279053Safco Universal X-Ray Film MountsSAFCO DENTAL SUPPLY CO.LXC2022-11-22