DENSOL
- Primary DI
- G8791048560
- Brand
- DENSOL
- Company
- DENSOL INTERNATIONAL (PRIVATE) LIMITED
- Model
- 104-856
- Catalog number
- 104-856
- Device description
- Vestibulum LipCheek Retractor
- Published
- 2026-08-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| EIG | Retractor, All Types |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EIG | Retractor, All Types | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| G8791048560 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Hand-held dental retractor | A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 775322952
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| G879101067S0 | DENSOL | 101-067S | 101-067S | 2026-08-13 |
| G879102177H0 | DENSOL | 102-177H | 102-177H | 2026-08-18 |
| G879102184H0 | DENSOL | 102-184H | 102-184H | 2026-08-18 |
| G8791021850 | DENSOL | 102-185 | 102-185 | 2026-08-18 |
| G879102185H0 | DENSOL | 102-185H | 102-185H | 2026-08-18 |
| G879102186H0 | DENSOL | 102-186H | 102-186H | 2026-08-18 |
| G879102187H0 | DENSOL | 102-187H | 102-187H | 2026-08-18 |
| G879102191H0 | DENSOL | 102-191H | 102-191H | 2026-08-18 |
| G879102196H0 | DENSOL | 102-196H | 102-196H | 2026-08-18 |
| G879102197H0 | DENSOL | 102-197H | 102-197H | 2026-08-18 |
| G879102211H0 | DENSOL | 102-211H | 102-211H | 2026-08-18 |
| G879102212H0 | DENSOL | 102-212H | 102-212H | 2026-08-18 |
| G879102213H0 | DENSOL | 102-213H | 102-213H | 2026-08-18 |
| G8791024050 | DENSOL | 102-405 | 102-405 | 2026-08-18 |
| G879102RM340 | DENSOL | 102-RM34 | 102-RM34 | 2026-08-18 |
| G8791062750 | DENSOL | 106-275 | 106-275 | 2026-08-18 |
| G879107193L0 | DENSOL | 107-193L | 107-193L | 2026-08-18 |
| G879107193S0 | DENSOL | 107-193S | 107-193S | 2026-08-18 |
| G879107241L0 | DENSOL | 107-241L | 107-241L | 2026-08-18 |
| G879107241M0 | DENSOL | 107-241M | 107-241M | 2026-08-18 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00190776426491 | Millennium | Avalign Technologies, Inc. | EIG | 2026-08-18 |
| 00190776426514 | Millennium | Avalign Technologies, Inc. | EIG | 2026-08-18 |
| 00190776426521 | Millennium | Avalign Technologies, Inc. | EIG | 2026-08-18 |
| 00190776426538 | Millennium | Avalign Technologies, Inc. | EIG | 2026-08-18 |
| G8791030240 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879103024L0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791030250 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791030260 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791030380 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791031820 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791031830 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879103185L0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879103185M0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879103185S0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791062470 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G8791062480 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879KLB25060 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879KLB36110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879KLB40110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879LB30100 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879LB35140 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879LB4013 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879OBG30100 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879OBG42110 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879OBG70140 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879WRL450 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879WRS350 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| G879ZYGOR180 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | EIG | 2026-08-15 |
| 00858466005608 | POLYTRACTOR | DENTAMERICA, INC. | EIG | 2026-07-27 |
| 00190776405946 | Millennium | Avalign Technologies, Inc. | EIG | 2026-07-26 |