FDA UDI In Commercial Distribution 🇺🇸 United States

T2, PANGEA

DI: 07613327649178 · Model: 543556 · Stryker GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
T2, PANGEA
Primary DI
07613327649178
Version / Model
543556
Catalog Number
543556
Company Name
Stryker GmbH
Labeler DUNS
481999654
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-25
Public Version
1
Public Version Date
2025-10-03
Public Version Status
New
Public Device Record Key
43306966-38d7-4878-a338-23109d6f4a3a

Device Description

Silicone Mat, Femur Reconstruction Tray

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
Yes
PM Exempt
Yes
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
FSM TRAY, SURGICAL, INSTRUMENT

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 07613327649178