DEVICE: Sentinelle (00884838103740)

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Device Record History
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Device Identifier (DI) Information
Sentinelle
459801813441
In Commercial Distribution

Philips Ds North America LLC
00884838103740
GS1

1
009237140 *Terms of Use
Sentinelle, Biopsy Grid
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45018 Needle guide, single-use
A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PXP Breast Biopsy / Localization Tray
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Temperature: between 10 and 24 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b63bf318-01e3-482d-8c89-200d16d59536
February 16, 2024
4
February 24, 2023
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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
10884838103747 10 00884838103740 In Commercial Distribution Box
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Secondary DI

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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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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