FDA UDI In Commercial Distribution 🇺🇸 United States

Patel Pipelle

DI: B296820010 · Model: 82001 · TITUS MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Patel Pipelle
Primary DI
B296820010
Version / Model
82001
Company Name
TITUS MEDICAL LLC
Labeler DUNS
080306309
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
095287c0-0979-4546-8fd1-37d44c32cb10

Device Description

Single unit

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
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
HHK Curette, Suction, Endometrial (And Accessories)

GMDN Terms

Code Name
11531 Endometrial biopsy kit

Identifiers

Type ID
Primary B296820010

Premarket Submissions

Submission Number Supplement Number
K990387 000