FDA.report

NA

Primary DI
00190886106269
Brand
NA
Company
G & H Wire Company, Inc.
Model
SKH012
Device description
SHORT KOBY HOOK 012
Published
2025-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190886106266PrimaryGS10
00190886106269Unit of UseGS10

GMDN Terms

TermDefinition
Orthodontic archwire/bracket ligatureA device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(317)346-6655orders@ghortho.com

Regulatory Flags

DUNS number
831465641
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00190886271028G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
00190886271035G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
00190886271042G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
00190886271059G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
00190886271066G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
00190886271073G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
00190886271080G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
00190886271097G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
00190886271103G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
00190886271110G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
00190886271127G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
00190886271134G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
00190886271141G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
00190886271158G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
00190886271165G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
00190886271172G&H ORTHODONTICS ®130-L5-8U-V2026-02-27
00190886271189G&H ORTHODONTICS ®130-L5-8RK-V2026-02-27
00190886271196G&H ORTHODONTICS ®130-L5-8LK-V2026-02-27
10190886271209G&H ORTHODONTICS ®130K-345-18-012026-02-27
10190886271216G&H ORTHODONTICS ®130K-3-18-012026-02-27

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00840479203218RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479202198ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202204ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202235ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
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