Model: 564--101
Catalog: 564--101
DI: 00652221099334
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
564-101 Gurin Retrtn Loop Small Right
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d081a0c2-7fb6-42d5-9fba-ba494e2b4234
Distribution Status:
In Commercial Distribution
DUNS Number:
008256356
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00652221099334
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35439
Name: Orthodontic clasp, metal, preformed
Definition:
A prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
ECN
CLAMP, WIRE, ORTHODONTIC