FDA.reportPublic FDA data

NA

Primary DI
10886982239884
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
530.412
Catalog number
530412
Device description
PROBE 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

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
10886982239884PrimaryGS10
H6795304120SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223988410886982239884

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

Regulatory Flags#

DUNS number
832637081
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14
10886982064745NA03.000.066S03000066S2016-06-30
10886982064820NA03.000.079S03000079S2016-06-30
10886982064844NA03.000.082S03000082S2016-06-30
10886982064882NA03.000.097S03000097S2016-06-30
10886982064905NA03.000.100S03000100S2016-06-30
10886982064929NA03.000.104S03000104S2016-06-30
10886982064936NA03.000.106S03000106S2016-06-30

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