FDA UDI In Commercial Distribution 🇺🇸 United States

Peri-Loc

DI: 00885556715581 · Model: XT001104-1 · Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Peri-Loc
Primary DI
00885556715581
Version / Model
XT001104-1
Catalog Number
XT001104-1
Company Name
Smith & Nephew, Inc.
Labeler DUNS
045483575
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-07
Public Version
4
Public Version Date
2024-02-19
Public Version Status
Update
Public Device Record Key
41093ac6-6373-4524-acaf-bd79c04fbc40

Device Description

4.5MM PROXIMAL FEMUR LOCKING PLATE 9H RT 10¿END

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
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
HRS Plate, fixation, bone

GMDN Terms

Code Name
61573 Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Identifiers

Type ID
Primary 00885556715581

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K072818 000