FDA UDI In Commercial Distribution 🇺🇸 United States

Reciproc Rotary Files

DI: D716TSTRCP06210251 · Model: TSTRCP0621025 · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

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Basic Information

Brand Name
Reciproc Rotary Files
Primary DI
D716TSTRCP06210251
Version / Model
TSTRCP0621025
Catalog Number
TSTRCP0621025
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2024-03-25
Public Version
1
Public Version Date
2024-04-02
Public Version Status
New
Public Device Record Key
17dc64ab-297a-46fa-9b6e-bde837fd4a96

Device Description

RECIPROC R25 21mm

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
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
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
63550 Rotary/reciprocating endodontic file/rasp, single-use

Identifiers

Type ID
Unit of Use D716TSTRCP06210250
Primary D716TSTRCP06210251