DEVICE: LoFric® Primo™ (07392532131677)

Device Identifier (DI) Information

LoFric® Primo™
41010
In Commercial Distribution
4101040
Dentsply Ih AB
07392532131677
GS1

1
354059073 *Terms of Use
Single Use Urinary Catheter LoFric Primo Nelaton 16" 10FR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Single-administration urethral catheterization kit, single-use A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 10 French
Length: 16 Inch
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Device Record Status

c0cfc2d4-e53f-4686-95b6-bd1a9652dc91
March 29, 2018
2
November 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07392532150531 4 07392532150524 In Commercial Distribution Transport Packaging
07392532150524 30 07392532131677 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)456-3742
info-lofric-usa@wellspect.com
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