FDA UDI In Commercial Distribution 🇺🇸 United States

SSW ENDO

DI: D690GPTFHMD2 · Model: U-GPTFHMD · Ss White Burs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SSW ENDO
Primary DI
D690GPTFHMD2
Version / Model
U-GPTFHMD
Catalog Number
GPTFHMD
Company Name
Ss White Burs, Inc.
Labeler DUNS
151760014
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-02-18
Public Version
2
Public Version Date
2025-05-07
Public Version Status
Update
Public Device Record Key
f3c572ea-8807-4f70-8d02-469c2b5b9500

Device Description

EXACTFLOW GUTTA PERCHA MEDIUM 60 PACK

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKM GUTTA-PERCHA

GMDN Terms

Code Name
31872 Natural gutta-percha

Identifiers

Type ID
Primary D690GPTFHMD2

Customer Contacts