Primary Device ID | D2485033020 |
NIH Device Record Key | 55faec85-f6f9-4ced-85a4-2da85ff1b77b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | COMPO-BLITZ NORMAL (THICKNESS: 1.5MM) NORMAL (12PCS.) |
Version Model Number | 503320 |
Company DUNS | 009277971 |
Company Name | HAGER WORLDWIDE, INC. |
Device Count | 12 |
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 | true |
Lot Batch | false |
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 | false |
OTC Over-The-Counter | false |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D2485033020 [Unit of Use] |
HIBCC | D2485033021 [Primary] |
EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-07 |
Device Publish Date | 2023-08-30 |
D248137720 - Almore Aluminum Oxide | 2024-05-28 Aluminum Oxide 1 lb. |
D248137730 - Almore Aluminum Oxide | 2024-05-28 Aluminum Oxide 4lb. |
D248B1619B0 - Duration | 2024-05-28 Air/Water Syringe Tips ( Stainless Steel) |
D248B16280 - Uni-Tip | 2024-05-28 Air/Water Syringe Tips |
D2481550180 - Reso-Pac Hydrophilic Periodontal Dressing | 2024-05-27 |
D2481550190 - Reso-Pac Hydrophilic Periodontal Dressing | 2024-05-27 |
D2483553190 - Plast Frame | 2024-04-24 Rubber dam frame |
D248222300 - SafeDispense - Silver | 2024-04-22 Floss Holder/dispenser |