Darby Dental Supply, LLC 9508268
GUDID 00889813013045
CSR Wraps 24 x 24 (500) DARBY
DARBY DENTAL SUPPLY, LLC
Sterilization packaging, single-use| Primary Device ID | 00889813013045 |
| NIH Device Record Key | 80aec6e9-1ba2-4d6f-88d2-8d5d47c4c246 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Darby Dental Supply, LLC |
| Version Model Number | 9508268 |
| Catalog Number | 9508268 |
| Company DUNS | 825137818 |
| Company Name | DARBY DENTAL SUPPLY, LLC |
| Device Count | 500 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889813012918 [Unit of Use] |
| GS1 | 00889813013045 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K931202
FDA Product Code
| FRG | Wrap, sterilization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-02-14 |
On-Brand Devices [Darby Dental Supply, LLC]
| D82795320301 | Cone Molded Earloop Face Mask |
| D82795187361 | MASK FORM FIT CONE PINK SMALL |
| D82795187351 | MASK FORM FIT CONE BLUE REGULAR |
| D82795187221 | MASK CONE MOLDED SMALL PINK |
| D82795186891 | MASK CONE MOLDED STANDARD BLUE |
| D82795151031 | MASK SURGICAL TIE-ON BLUE |
| D82795004250 | ALGINATE DUSTLESS FAST SET 22LB |
| D82795004200 | ALGINATE DUSTLESS REGULAR SET 22LB |
| D82795004150 | ALGINATE DUSTLESS REGULAR SET 1LB |
| D82795004100 | ALGINATE DUSTLESS FAST SET 1LB |
| D82794306620 | Temporary Filling Material Syringe 5g |
| D82794306600 | Temporary Filling Material 18g Jar |
| 00366467000015 | HEDSTROM FILE W/STOP 21MM #15 DARBY |
| 40889813000678 | STERILIZATION POUCH 3.5 X 9 |
| 10889813017958 | 5% Clear Sodium Fluoride Varnish Melon 500ct |
| 10889813017941 | 5% Clear Sodium Fluoride Varnish Melon 50ct |
| 10889813017927 | 5% Clear Sodium Fluoride Varnish Mint 500ct |
| 10889813017910 | 5% Clear Sodium Fluoride Varnish Mint 50ct |
| 10889813017897 | 5% SODIUM FL VARNISH CARAMEL DARBY |
| 10889813017880 | 5% SODIUM FL VARNISH CARAMEL DARBY |
| 10889813017866 | 5% SODIUM FL CLR VARNISH BGUM DARBY |
| 10889813017859 | 5% SODIUM FL CLR VARNISH BGM DARBY |
| 10889813013899 | MIRROR SIMPLE STEM PLANE #5 DARBY |
| 10889813004125 | CARBIDE BUR FG 7803 DARBY |
| 10889813003234 | SUTURE SILK 3/8 NC-2 3/0 18" DARBY |
| 10889813002695 | Pit & Fissure Sealant |
| 10889813002466 | Polysiloxane Bite Super Fast Set Wintermint 50ml CART |
| 10889813002107 | PVS Impression Material Regular Set Light Body Raspberry 50ML |
| 10889813001933 | PVS Impression Material Fast Set Light Body Wintermint 50ml |
| 10889813001926 | PVS Impression Material Regular Set Light Body Wintermint 50ml |
| 10889813001919 | PVS Impression Material Fast Set Heavy Body Unflav 50ml |
| 10889813001902 | PVS Impression Material Fast Set Monophase Body Unflav 50ml |
| 10889813001896 | PVS Impression Material Fast Set Medium Body Unflav 50ml |
| 10889813001889 | PVS Impression Material Fast Set Light Body Unflavored 50ml |
| 10889813001773 | Cone Molded Earloop Face Mask |
| 10889813001766 | MASK FORM FIT CONE PINK SMALL |
| 10889813001759 | MASK FORM FIT CONE BLUE REGULAR |
| 10889813001742 | MASK CONE MOLDED SMALL PINK |
| 10889813001735 | MASK CONE MOLDED STANDARD BLUE |
| 10889813001728 | MASK SURGICAL TIE-ON BLUE |
| 10889813001698 | Alginate Substitute Fast Set 50ml CART |
| 10889813001681 | Alginate Substitute Regular Set 50ml CART |
| 20889813001428 | SLEEVE T-STYLE HANDLE |
| 20889813001411 | CHAIR SLEEVE HALF 27.5 x 24 |
| 20889813001404 | CHAIR SLEEVE FULL 29" X 80" |
| 20889813001398 | X-Ray Sleeves 15x26 |
| 20889813001381 | TRAY SLEEVES 10.5" X 14" |
| 20889813001374 | TRAY SLEEVES 11.5" X 16" |
| 20889813001367 | Low-speed handpiece sleeves 1.5 x 8 |
| 20889813001350 | Syringe Sleeves A/W Clear |
Trademark Results [Darby Dental Supply, LLC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DARBY DENTAL SUPPLY, LLC 85488180 4182856 Live/Registered |
Darby Group Companies, Inc. 2011-12-06 |
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