Primary Device ID | D909800063A1 |
NIH Device Record Key | c94c368f-c83b-4928-9bdb-e1fc8fd540a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPECTRUM |
Version Model Number | ANTERIOR BRACKET REMOVER |
Catalog Number | 800-063A |
Company DUNS | 020956330 |
Company Name | Ortho Arch Company Inc |
Device Count | 1 |
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 | false |
Lot Batch | true |
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 |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D909800063A1 [Primary] |
JEX | Plier, Orthodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
[D909800063A1]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-03 |
Device Publish Date | 2022-09-24 |
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D9098001271 | SPECTRUM THREE PRONG CLASP PLIER |
D9098001251 | SPECTRUM UTILITY ARCH 3MM STEP PLIER |
D9098001241 | SPECTRUM ANGLED UTILITY ARCH PLIER |
D9098001231 | SPECTRUM UTILITY ARCH PLIER |
D9098000881 | SPECTRUM LOOP TIE BACK PLIER |
D9098000871 | SPECTRUM GTS CRIMPING PLIER |
D9098000741 | SPECTRUM ADHESIVE REMOVER |
D909800063A1 | SPECTRUM ANTERIOR BRACKET REMOVER |
D9098000631 | SPECTRUM DIRECT BOND BRACKET REMOVER - ANGLED |
D9098000611 | SPECTRUM OPTICAL PLIER (OCCULIST) |
D9098000441 | SPECTRUM TWEED LOOP FORMING PLIERS |
D9098001321 | SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER |
D9098001311 | SPECTRUM WIDE REPLACEMENT KEY |
D9098001302 | SPECTRUM TORQUING PLIER SET W/ WIDE KEY |
D9098001290 | SPECTRUM LINGUAL ARCH FORMING PLIER |