FDA UDI In Commercial Distribution 🇺🇸 United States

PANGEA

DI: 07613327624892 · Model: 542135 · Stryker GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PANGEA
Primary DI
07613327624892
Version / Model
542135
Catalog Number
542135
Company Name
Stryker GmbH
Labeler DUNS
481999654
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-27
Public Version
4
Public Version Date
2026-04-01
Public Version Status
Update
Public Device Record Key
7f03070b-79de-4624-b8c3-31dccb659d51

Device Description

Locking Nut, MIS

Device Characteristics

Single Use
No
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
HWC Screw, fixation, bone
HRS Plate, fixation, bone

GMDN Terms

Code Name
47779 Orthopaedic instrument surgical connector

Identifiers

Type ID
Primary 07613327624892

Device Sizes

Type Value Unit Text
Length 40.0 Millimeter