FitStrip™ FPSK02

GUDID 00810038094014

Single-Sided Kit: (2) Serrated Strips, (8) Single-Sided Strips - 2 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (2) Handles

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental abrasive strip, single-use

• Primary Device ID: 00810038094014
• NIH Device Record Key: 33da11b7-5e5a-4429-9deb-7c28c47c94c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FitStrip™
• Version Model Number: FPSK02
• Catalog Number: FPSK02
• 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

Customer Support Contacts

• Phone: 888-437-0032
• Email: gds@garrisondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038094014 [Primary]

FDA Product Code

• DZP: Instrument, Diamond, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810038094014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

On-Brand Devices [FitStrip™]

• 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