FDA.reportPublic FDA data

NA

Primary DI
H6795304120
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
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10705034711874ATB03.601.110036011102016-12-31
10705034711881ATB03.601.111036011112016-12-31
10705034711898ATB03.601.112036011122016-12-31
10705034711904ATB03.601.113036011132016-12-31
10705034711911ATB03.601.114036011142016-12-31
10705034711928ATB03.601.115036011152016-12-31
10705034711935ATB03.601.116036011162016-12-31
10705034711942ATB03.601.117036011172016-12-31
10705034711959ATB03.601.118036011182016-12-31
10705034711966ATB03.601.140036011402016-12-31
10705034711973ATB03.601.142036011422016-12-31
10705034711980ATB03.601.144036011442016-12-31
10705034711997ATB03.601.146036011462016-12-31
10705034712000ATB03.601.148036011482016-12-31
10705034712017ATB03.601.150036011502016-12-31
10705034712024ATB03.601.152036011522016-12-31
10705034712031ATB03.601.154036011542016-12-31
10705034712048ATB03.601.156036011562016-12-31
10705034712055ATB03.601.170036011702016-12-31
10705034712062ATB03.601.172036011722016-12-31

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