FDA UDI In Commercial Distribution 🇺🇸 United States

Procedure Product Torque Device

DI: B16080141 · Model: 8014 · PROCEDURE PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Procedure Product Torque Device
Primary DI
B16080141
Version / Model
8014
Company Name
PROCEDURE PRODUCTS, INC.
Labeler DUNS
151507563
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-12
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
a00a4914-af97-4767-80dd-803b613d236e

Device Description

TORQUE DEVICE, WHITE

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DQX Wire, Guide, Catheter

GMDN Terms

Code Name
46455 Torque manipulation device

Identifiers

Type ID
Primary B16080141