Arch Wire

GUDID D972AMC192534MMUOF1TST0

Orthodontic archwire

Primary Device ID	D972AMC192534MMUOF1TST0
NIH Device Record Key	1877c5df-e45d-4b0b-ae34-5b6d849c9f35
Commercial Distribution Status	In Commercial Distribution
Brand Name	Arch Wire
Version Model Number	AMC192534MMUOF1TST
Company DUNS	118370238
Company Name	Acme Monaco Corporation
Device Count	10
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D972AMC192534MMUOF1TST0 [Unit of Use]
HIBCC	D972AMC192534MMUOF1TST2 [Primary]

DZC	Wire, Orthodontic

Steralize Prior To Use	false
Device Is Sterile	false

D972AMC1030NTI150 - Spring	2024-09-30 NiTi open coil spring .010" x .030", 15" (380mm) spool
D972AMC1616LGRST0 - Archwire	2024-09-30 SS Euro-Form square archwire lower .016" x .016" (Pack of 10 pieces)
D972AMC1818UNAT0 - Archwire	2024-09-30 SS Full-Form square archwire upper .018" x .018" (Pack of 10 pieces)
D972AMC1925LMRGM0 - Archwire	2024-09-30 NiTi Thermal Euro-Form rectangle archwire lower .019" x .025" (Pack of 10 pieces)
D97261014020130 - Spring	2024-09-25 NITI OPEN COIL 15" .010X.030
D97267022020120 - Ligature	2024-09-25 KOBAYSHI 012 TWIST SHORT
D97277G0L200160 - Archwire	2024-09-25 NITI REVERSE 016 L PK10
D97277G0L200180 - Archwire	2024-09-25 NITI REVERSE 018 L PK10