Surgiform ND-10B
GUDID 00851988007556
"ND-10B Nasal Dorsal Series B Silicone Implants"
SURGICAL TECHNOLOGY LABORATORIES INC
Nasal implant, synthetic polymer, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable| Primary Device ID | 00851988007556 |
| NIH Device Record Key | 61fd2a85-28db-4d5d-945b-56cec813667e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgiform |
| Version Model Number | ND-10B |
| Catalog Number | ND-10B |
| Company DUNS | 080380106 |
| Company Name | SURGICAL TECHNOLOGY LABORATORIES INC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851988007556 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K983755
FDA Product Code
| FZE | Prosthesis, Nose, Internal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Surgiform]
| 00851988007976 | SB-6MF Silicone Block - Size Three - Med Duro - Flesh Tone |
| 00851988007969 | SB-6MC Silicone Block - Size Six - Med Duro-Clear |
| 00851988007952 | SB-6SF Silicone Block - Size Six -Soft -Flesh Tone |
| 00851988007945 | SB-6SC Silicone Block - Size Six - Soft -Clear |
| 00851988007938 | "SB-3MF Silicone Block - Size Three - Med Duro - Flesh Tone" |
| 00851988007921 | "SB-3SF Silicone Block - Size Three -Soft -Flesh Tone" |
| 00851988007914 | "SB-3SC Silicone Block - Size Three - Soft -Clear" |
| 00851988007907 | "SB-03 Silicone Block - Size Three - Med Duro-Clear" |
| 00851988007891 | "SB-2MF Silicone Block - Size Two - Med Duro -Flesh Tone" |
| 00851988007884 | "SB-2SF Silicone Block - Size Two - Soft -Flesh Tone Silicone Implants" |
| 00851988007877 | "SB-2SC Silicone Block - Size Two - Soft -Clear" |
| 00851988007860 | "SB-02 Silicone Block - Size Two - Med Duro - Clear" |
| 00851988007853 | "SB-1MF Silicone Block - Size One - Med Duro -Flesh Tone Silicone Implants" |
| 00851988007846 | "SB-1SC Silicone Block - Size One - Soft -Clear Silicone Implants" |
| 00851988007839 | "SB-1SF Silicone Block - Size One - Soft -Flesh Tone Silicone Implants" |
| 00851988007822 | "SB-01 Silicone Block - Size One - Med Duro - Clear Silicone Implants" |
| 00851988007815 | "TM-04 Trapezoidal Malar Silicone Implants" |
| 00851988007808 | "TM-03 Trapezoidal Malar Silicone Implants" |
| 00851988007792 | "TM-02 Trapezoidal Malar Silicone Implants" |
| 00851988007785 | "TM-01 Trapezoidal Malar Silicone Implants" |
| 00851988007778 | "SM-06 Standard Malar Silicone Implants" |
| 00851988007761 | "SM-05 Standard Malar Silicone Implants" |
| 00851988007754 | "SM-04 Standard Malar Silicone Implants" |
| 00851988007747 | "SM-03 Standard Malar Silicone Implants" |
| 00851988007730 | "SM-02 Standard Malar Silicone Implants" |
| 00851988007723 | "SM-01 Standard Malar Silicone Implants" |
| 00851988007716 | "SC-06 Standard Chin - Size 6 Silicone Implants" |
| 00851988007709 | "SC-05 Standard Chin Silicone Implants" |
| 00851988007693 | "SC-04 Standard Chin Silicone Implants" |
| 00851988007686 | "SC-03 Standard Chin Silicone Implants" |
| 00851988007679 | "SC-02 Standard Chin Silicone Implants" |
| 00851988007662 | "SC-01 Standard Chin Silicone Implants" |
| 00851988007655 | "OFD2-03 Ofodile Series II Silicone Implants" |
| 00851988007648 | "OFD2-02 Ofodile Series II Silicone Implants" |
| 00851988007631 | "OFD2-01 Ofodile Series II Silicone Implants" |
| 00851988007624 | "OFD1-03 Ofodile Series I Silicone Implants" |
| 00851988007617 | "OFD1-02 Ofodile Series I Silicone Implants" |
| 00851988007600 | "OFD1-01 Ofodile Series I Silicone Implants" |
| 00851988007594 | "ND-14C Nasal Dorsal Series C Silicone Implants" |
| 00851988007587 | "ND-13C Nasal Dorsal Series C Silicone Implants" |
| 00851988007570 | "ND-12C Nasal Dorsal Series C Silicone Implants" |
| 00851988007563 | "ND-11C Nasal Dorsal Series C Silicone Implants" |
| 00851988007556 | "ND-10B Nasal Dorsal Series B Silicone Implants" |
| 00851988007549 | "ND-09B Nasal Dorsal Series B Silicone Implants" |
| 00851988007532 | "ND-08B Nasal Dorsal Series B Silicone Implants" |
| 00851988007525 | "ND-07B Nasal Dorsal Series B Silicone Implants" |
| 00851988007518 | "ND-06B Nasal Dorsal Implant Silicone Implants" |
| 00851988007501 | "ND-05A Nasal Dorsal Series A Silicone Implants" |
| 00851988007495 | "ND-05 Nasal Dorsal - Size 05 Silicone Implants" |
| 00851988007488 | "ND-04A Nasal Dorsal Series A Silicone Implants" |
Trademark Results [Surgiform]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIFORM 74591929 1948486 Live/Registered |
Surgiform Technology, Ltd. 1994-10-28 |
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