FDA UDI Not in Commercial Distribution 🇺🇸 United States

Rotation Medical Arthroscopic Implant Set With Staples

DI: 00854501006043 · Model: 2516 · Smith & Nephew, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Rotation Medical Arthroscopic Implant Set With Staples
Primary DI
00854501006043
Version / Model
2516
Catalog Number
2516-1
Company Name
Smith & Nephew, Inc.
Labeler DUNS
045483575
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-23
Public Version
7
Public Version Date
2023-09-07
Public Version Status
Update
Public Device Record Key
8ecec753-f1da-4a3d-a322-be0a5a80e63a
Distribution End Date
2020-10-16

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue

GMDN Terms

Code Name
45062 Tendon/ligament bone anchor, non-bioabsorbable
44093 Arthroscopic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Primary 00854501006043