5P BLK VARIBLE PULL HEADCAP *O
- Primary DI
- D7753001000
- Brand
- 5P BLK VARIBLE PULL HEADCAP *O
- Company
- GREAT LAKES ORTHODONTICS, LTD.
- Model
- 300-100
- Catalog number
- 300-100
- Device description
- 5P BLK VARIBLE PULL HEADCAP *O
- Published
- 2016-05-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DZB | Headgear, Extraoral, Orthodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZB | Headgear, Extraoral, Orthodontic | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D7753001000 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthodontic extraoral headgear | A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear). |
Regulatory Flags
- DUNS number
- 041854332
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D7753004000 | SM DRYFIELD KIT RED *I | 300-400 | 300-400 | 2016-05-18 |
| D7753004010 | LG DRYFIELD KIT WHITE *I | 300-401 | 300-401 | 2016-05-18 |
| D7753004060 | RETRACTOR - LARGE WHITE *I | 300-406 | 300-406 | 2016-05-18 |
| D7753004140 | RETRACTOR - SMALL RED *I | 300-414 | 300-414 | 2016-05-18 |
| D7753006120 | LARGE LIP RETRACTOR *O | 300-612 | 300-612 | 2016-05-18 |
| D7753006140 | SMALL LIP RETRACTOR *O | 300-614 | 300-614 | 2016-05-18 |
| D7753006260 | GL INTRAORAL MOUTH PROPS | 300-626 | 300-626 | 2016-05-18 |
| D7753006270 | GL INTRAORAL MOUTH PROPS | 300-627 | 300-627 | 2016-05-18 |
| D7753006280 | GL INTRAORAL MOUTH PROPS | 300-628 | 300-628 | 2016-05-18 |
| D7753006290 | GL DOUBLE-ENDED CHEEK | 300-629 | 300-629 | 2016-05-18 |
| D7753006300 | GL DOUBLE-ENDED CHEEK | 300-630 | 300-630 | 2016-05-18 |
| D7753006310 | GL EXTRAORAL CHEEK RETRACTORS | 300-631 | 300-631 | 2016-05-18 |
| D7753006320 | GL EXTRAORAL CHEEK RETRACTORS | 300-632 | 300-632 | 2016-05-18 |
| D7751400151 | GL ACCULIGHT EXPANSION KEY | 140-015 | 140-015 | 2016-05-18 |
| D7751400201 | GLO EZKEY PKG/10 *O | 140-020 | 140-020 | 2016-05-18 |
| D7751910211 | GLO MOUTHGUARD - PINK (DZ) *I | 191-021 | 191-021 | 2016-05-18 |
| D7751910221 | GLO MOUTHGUARD PINK (DZ) *I | 191-022 | 191-022 | 2016-05-18 |
| D7751910231 | GLO MOUTHGUARD PURPLE (DZ) *I | 191-023 | 191-023 | 2016-05-18 |
| D7751910241 | GLO MOUTHGUARD PURPLE (DZ) *I | 191-024 | 191-024 | 2016-05-18 |
| D7751910251 | GLO MOUTHGUARD ASST'D (DZ) *I | 191-025 | 191-025 | 2016-05-18 |
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