DeRoyal

Primary DI
00749756108768
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M9215
Catalog number
M9215
Device description
WEIGHTS
Published
2021-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HSTApparatus, traction, non-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756108768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756108768007497561087687497561087680749756108768

GMDN Terms

TermDefinition
Vertical non-powered traction systemAn assembly of devices designed to be wall-mounted for the application of constant vertical traction forces to the cervical vertebrae by means of attached harnesses. The assembly usually consists of several specialized harnesses, a combination of pulleys and cords, and a set of weights that hang from the cords as the source of the traction force (or the patient's own weight may be used). Adjustable spreader bars may be used to vary the angle at which the cord applies the traction. Patients are typically seated on a traction chair or the device may be temporarily attached to a door. The assembly is used in orthopaedic and/or physical therapy procedures.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

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