DEVICE: InnoFine (06971554726316)

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Device Record History
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Device Identifier (DI) Information
InnoFine
DEK-001
In Commercial Distribution
10631
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
06971554726316
GS1

1
544571975 *Terms of Use
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 6CV1(s,P), CB10-4(s,P,E,A), V10-4(s), V10-4B(s,P), V11-3(E,s), V11-3B(E), V11-3W(s,E), E9-3, V11-3H(E,U,s); |Wisonic| EV10-4, EV11-3-H; |Landwind| EC4-9; |Samsung| EC4-9IS, EC4-9ES, ER4-9ES; |GE Healthcare| IC5-9; |VINNO| G4-9E, X4-9E, F4-9E; |Zoncare| 6E1CD ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
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Device Characteristics
Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
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
OIJ Biopsy Needle Guide Kit
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Away from Sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ef170432-432c-46fe-b634-c02ea089f2e3
February 20, 2025
1
February 12, 2025
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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
16971554726313 24 06971554726316 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
Yes
No CLOSE

Customer Contact

[?]
+8675527597952
Sales@innofine.cn
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