DEVICE: RANFAC BREAST MRK, 7.5CM F/G (M9796000403M0)

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Device Record History
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Device Identifier (DI) Information
RANFAC BREAST MRK, 7.5CM F/G
7.5 CM
In Commercial Distribution
SBS-7.5
RANFAC CORP.
M9796000403M0
HIBCC

1
121622872 *Terms of Use
RANFAC BREAST MRK, 7.5CM F/G SBS-7.5 PN 60004-03M
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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
GDF Guide, Needle, Surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K845038 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 7.5 Centimeter
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Device Record Status
939599d9-4a4f-40f4-8eff-0466533c9fd6
February 16, 2024
9
May 04, 2017
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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
M9796000403M9 16 M9796000403M1 In Commercial Distribution Case
M9796000403M1 10 M9796000403M0 In Commercial Distribution Inner Pack
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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

[?]
5085884400
info@ranfac.com
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