DEVICE: E.M Adams co, inc. (10840200301906)

Device Identifier (DI) Information

E.M Adams co, inc.
14-3346-1
In Commercial Distribution

E.M. ADAMS, INC.
10840200301906
GS1

1
001403807 *Terms of Use
SINGLE INSTRUMENT
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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?
57874 Suturing unit, single-use
A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FSM Tray, Surgical, Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K812133 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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

[?]
Size Type Text
Device Size Text, specify: 5" X 9" POUCH/MAYO HEAGER NEEDLE HOLDER
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Device Record Status

ba42e3d5-a817-4fce-9cc7-95fbe9d77a83
May 31, 2021
1
May 21, 2021
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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
50840200301898 100 10840200301906 In Commercial Distribution Case
30840200301917 20 10840200301906 In Commercial Distribution BX
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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(772)461-0532
EMADAMS@EMADAMSCO.COM
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