FDA.report

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Primary DI
05055662923728
Brand
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS328001
Catalog number
OS328001
Device description
FPS 2.7/3.5 DEPTH GAUGE
Published
2016-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055662923728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055662923728050556629237285055662923728

GMDN Terms

TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+441621843599quality@orthosol.com

Regulatory Flags

DUNS number
218648211
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

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05055662970524ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353025-NSOS353025-NS2025-08-15
05055662970531ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353502-NSOS353502-NS2025-08-15
05055662970548ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353503-NSOS353503-NS2025-08-15
05055662970555ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353504-NSOS353504-NS2025-08-15
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