Primary Device ID | 00810038096537 |
NIH Device Record Key | f0622fcb-dd9c-4dcb-bcb2-22d8f3a0587b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FitStrip™ |
Version Model Number | FPSGMSS |
Catalog Number | FPSGMSS |
Company DUNS | 057647005 |
Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
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 | true |
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 |
---|---|
GS1 | 00810038096537 [Primary] |
GS1 | 10810038096565 [Package] Package: FPSGMSS-4 [4 Units] In Commercial Distribution |
DZP | Instrument, Diamond, Dental |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
[00810038096537]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-03 |
Device Publish Date | 2021-01-26 |
00810038095240 | IPR Sample Pack: (1) 0.40mm Double-Sided Strip, (1) 0.50mm Double-Sided Strip, (1) Handle |
00810038095233 | Trial Kit: (1) Serrated Strip, (1) 0.08mm Single-Sided Strip, (1) Handle |
00810038094182 | Double-Sided, Medium Grit, Black |
00810038094175 | Strip Refill, Double-Sided, Medium Grit, Black: 10 Strips, 2 Handles |
00810038094168 | Single-Sided, Super Fine Grit, Yellow |
00810038094151 | Strip Refill, Single-Sided, Super Fine Grit, Yellow: 10 Strips, 2 Handles |
00810038094144 | Double-Sided, Super Fine Grit, Yellow |
00810038094137 | Strip Refill, Double-Sided, Super Fine Grit, Yellow: 10 Strips, 2 Handles |
00810038094120 | Double-Sided, Medium Grit, White |
00810038094113 | Strip Refill, Double-Sided, Medium Grit, White: 10 Strips, 2 Handles |
00810038094106 | Serrated, Gray |
00810038094090 | Strip Refill, Serrated, Gray: 10 Strips, 2 Handles |
00810038094083 | Single-Sided, Medium Grit, Blue |
00810038094076 | Strip Refill, Single-Sided, Medium Grit, Blue: 10 Strips, 2 Handles |
00810038094069 | Double-Sided, Medium Grit, Blue |
00810038094052 | Strip Refill, Double-Sided, Medium Grit, Blue: 10 Strips, 2 Handles |
00810038094045 | IPR Kit: (1) IPR Gauge, (10) Double-Sided Strips - 2 of Each 0.11mm, 0.21mm, 0.30mm, 0.40mm, 0.5 |
00810038094038 | Universal Kit: (1) IPR Gauge, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm |
00810038094021 | Double-Sided Kit: (2) Serrated Strips, (8) Double-Sided Strips - 2 of Each 0.11mm, 0.15mm, 0.21m |
00810038094014 | Single-Sided Kit: (2) Serrated Strips, (8) Single-Sided Strips - 2 of Each 0.08mm, 0.10mm, 0.13m |
00810038094007 | Starter Kit: (2) Serrated Strips, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0. |
00810038093994 | Replacement Handle |
00810038093987 | IPR Gauge |
00810038093970 | Single-Sided, Fine Grit, Red |
00810038093963 | Strip Refill, Single-Sided, Fine Grit, Red: 10 Strips, 2 Handles |
00810038093956 | Double-Sided, Fine Grit, Red |
00810038093949 | Strip Refill, Double-Sided, Fine Grit, Red: 10 Strips, 2 Handles |
00810038093932 | Single-Sided, Coarse Grit, Green |
00810038093925 | Strip Refill, Single-Sided, Coarse Grit, Green: 10 Strips, 2 Handles |
00810038093918 | Double-Sided, Coarse Grit, Green |
00810038093901 | Strip Refill, Double-Sided, Coarse Grit, Green: 10 Strips, 2 Handles |
00810038096599 | FitStrip Subgingival Sample Pack |
00810038096582 | FitStrip Subgingival Finishing and Single-Sided Kit |
00810038096575 | FitStrip Subgingival Finishing Kit |
00810038096568 | FitStrip Subgingival single-sided medium grit: 1 strip |
00810038096551 | FitStrip Subgingival single-sided fine grit: 1 strip |
00810038096544 | FitStrip Subgingival single-sided super fine grit: 1 strip |
00810038096537 | FitStrip Subgingival single-sided medium grit: 10 strips, 2 handles |
00810038096520 | FitStrip Subgingival single-sided fine grit: 10 strips, 2 handles |
00810038096513 | FitStrip Subgingival single-sided super fine grit: 10 strips, 2 handles |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FITSTRIP 87182770 not registered Dead/Abandoned |
Fitstrip Holding LLC 2016-09-26 |