DEVICE: G4 NICKEL TITANIUM SOLO-PACK (10190886022320)

Device Identifier (DI) Information

G4 NICKEL TITANIUM SOLO-PACK
RCDG172534S
In Commercial Distribution

G & H Wire Company, Inc.
10190886022320
GS1

1
831465641 *Terms of Use
G4 RC EFII LN PTORQ 017x025 UNIV 34MM SOLO
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
41397 Orthodontic archwire
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DZC WIRE, ORTHODONTIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
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
Height: .017 Inch
Width: .025 Inch
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Device Record Status

fb82f42f-7b00-44cc-9191-695843a6a433
April 04, 2025
1
March 27, 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
20190886022327 10 10190886022320 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
No
Yes
No CLOSE

Customer Contact

[?]
+1(317)346-6655
orders@ghortho.com
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