FDA UDI In Commercial Distribution 🇺🇸 United States

Native

DI: 00850075111015 · Model: 201.000 · INS ORTHO INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Native
Primary DI
00850075111015
Version / Model
201.000
Catalog Number
201.000
Company Name
INS ORTHO INC.
Labeler DUNS
145088199
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-26
Public Version
1
Public Version Date
2026-03-06
Public Version Status
New
Public Device Record Key
4ce1dd8d-1347-44a3-81c3-71bbf6f9d9fd

Device Description

2.4mm Cannulated Drill

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
61235 Cannulated surgical drill bit, single-use

Identifiers

Type ID
Primary 00850075111015

Customer Contacts

Phone
401-400-5742