FDA.report

ORTHO SOLUTIONS STERILE DRILL BITS

Primary DI
05055662923575
Brand
ORTHO SOLUTIONS STERILE DRILL BITS
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS307100
Catalog number
OS307100
Device description
MTP REAMER SYSTEM STERILISATION TRAY
Published
2017-01-20
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
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055662923575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055662923575050556629235755055662923575

GMDN Terms

TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

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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05055662970449ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353002-NSOS353002-NS2025-08-15
05055662970456ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353006-NSOS353006-NS2025-08-15
05055662970487ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353021-NSOS353021-NS2025-08-15
05055662970517ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353024-NSOS353024-NS2025-08-15
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
05055662970562ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353506-NSOS353506-NS2025-08-15
05055662970579ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353508-NSOS353508-NS2025-08-15
05055662970586ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353509-NSOS353509-NS2025-08-15
05055662970609ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353003L-SOS353003L-S2025-08-15

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