FDA.report

OIC Suture Anchor System

Primary DI
10811998038756
Brand
OIC Suture Anchor System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
01-SA00
Device description
STERILIZATION CASE, SUTURE ANCHORS
Published
2021-05-26
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
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions

SubmissionSupplement
K182736000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K182736000OIC Suture Anchor SystemThe Orthopaedic Implant Company2018-12-28MBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10811998038756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081199803875610811998038756

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
775 636 8281Info@OrthoImplantCompany.com

Regulatory Flags

DUNS number
070061160
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
true
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 DIBrandModelCatalogPublished
10811998032150OIC Cannulated Screw System01-SHS102018-07-31
10811998036301OIC Intramedullary Nail System01-IM302018-07-31
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036394OIC Intramedullary Nail System01-IM412018-07-31
10811998036561OIC Intramedullary Nail System01-IM582018-08-07
10811998038022OIC Intramedullary Nail System01-IMSE032018-08-07
10811998038039OIC Intramedullary Nail System01-IMSE042018-08-07
M69601IM300OIC Intramedullary Nail System01-IM302017-02-01
M69601IM320OIC Intramedullary Nail System01-IM322017-02-01
M69601IM340OIC Intramedullary Nail System01-IM342017-02-01
M69601IM400OIC Intramedullary Nail System01-IM402017-02-01
M69601IM410OIC Intramedullary Nail System01-IM412017-02-01
M69601SHS100OIC Cannulated Screw System01-SHS102017-02-01
10811998039845OIC Variable Angle Small Fragment Locking Plate SystemPHP-09172L2024-09-06
10811998039852OIC Variable Angle Small Fragment Locking Plate SystemPHP-09172R2024-09-06
10811998031924OIC Variable Angle Small Fragment Locking Plate System01-SF282024-06-20
10811998030224OIC Cannulated Screw System07-0362024-06-05
10811998030248OIC Cannulated Screw System13-0662024-06-05

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