DEVICE: EXEL SRGCL BLADE,S-S, SIZE:15 (00020221295085)

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Device Record History
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Device Identifier (DI) Information
EXEL SRGCL BLADE,S-S, SIZE:15
29508
In Commercial Distribution
29508
Exel International
00020221295085
GS1

1
180572216 *Terms of Use
EXEL SRGCL BLADE,S-S, SIZE:15; 100/BX, 1000/CS, 10CS/CRTN
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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?
37445 Manual scalpel blade, single-use
An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GES Blade, Scalpel
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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 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c99d2478-cb49-4385-ac94-09b649827812
March 27, 2023
1
March 17, 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
10020221295082 100 00020221295085 In Commercial Distribution Inner box
20020221295089 10 10020221295082 In Commercial Distribution Outer box
30020221295086 10 20020221295089 In Commercial Distribution Shipping carton
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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