Shukla Trephine S9TREPHINE

Basic Information

• Brand Name: Shukla Trephine S9TREPHINE
• Primary DI: B756STR00118SP0
• Version / Model: STR001-18-SP
• Company Name: Shukla Medical
• Labeler DUNS: 159009294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-21
• Public Version: 2
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: 9ee72f58-d3a8-4640-b0a2-27631065f0ce

Device Description

Trephine, 18mm, Single Use, Sterile Packed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWK	Trephine	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64237	Orthopaedic inorganic implant inserter/extractor, single-use	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B756STR00118SP1	HIBCC		1	In Commercial Distribution
Primary	B756STR00118SP0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 30 Degrees Celsius