DEVICE: N/A (10705036003465)

Device Identifier (DI) Information

N/A
CDH29A
In Commercial Distribution
CDH29A
ETHICON ENDO-SURGERY, LLC
10705036003465
GS1

1
044606982 *Terms of Use
Curved Intraluminal Stapler (ILS) 24 Titanium Adjustable Height Staples
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Device Characteristics

MR Conditional
No
No
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?
59875 Intraluminal circular stapler, single-use
A sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GDW STAPLE, IMPLANTABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K983536 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
No Device Sizes
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Device Record Status

3b9429e7-ea41-4129-a92d-300cfadaa581
November 06, 2023
6
August 24, 2015
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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
20705036003462 3 10705036003465 In Commercial Distribution BOX
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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)384-4266
customersupport@eesus.jnj.com
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