FDA UDI In Commercial Distribution 🇺🇸 United States

Shukla Spine-TL S9SPINE-TL,Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C

DI: B756SXN0070 · Model: SXN007 · Shukla Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Shukla Spine-TL S9SPINE-TL,Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C
Primary DI
B756SXN0070
Version / Model
SXN007
Company Name
Shukla Medical
Labeler DUNS
159009294
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-12
Public Version
2
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
268b55ef-07f4-4f8e-9601-d11d4ab1cdc8

Device Description

Extension Assy, 4"

Device Characteristics

Single Use
No
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary B756SXN0070

Customer Contacts