AccessGUDID - DEVICE: NA (10886982239914)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 530.413
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 530413
Company Name: Synthes GmbH

Primary DI Number: 10886982239914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: CABLE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58297	Compartmental-pressure monitoring system, reusable	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXC	MONITOR, PRESSURE, INTRACOMPARTMENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031555	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b105a3b4-1257-4853-82c7-9ff3707e5fae
Public Version Date: April 25, 2022
Public Version Number: 5
DI Record Publish Date: December 31, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	H6795304130

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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