| Primary Device ID | D2486054601 |
| NIH Device Record Key | 5f7f5b73-2e57-4ce0-babf-77e668651f8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spandex Advanced Kit ( 1 Standard/ 1 Large) |
| Version Model Number | 605460 |
| Company DUNS | 009277971 |
| Company Name | HAGER WORLDWIDE, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| 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 | |
| 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 | D2486054601 [Primary] |
| EIF | ACCESSORIES, RETRACTOR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
[D2486054601]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-24 |
| Device Publish Date | 2023-10-16 |
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| D2483552600 - BurButler ( 25 Hole Pink Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552620 - BurButler ( 25 Hole Blue Base w/Lid) | 2024-07-23 Dental bur holder |