ANOSPEC C060120
GUDID M648C0601202
103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE
OBP CORPORATION
Optical anoscope, single-use| Primary Device ID | M648C0601202 |
| NIH Device Record Key | 81b7dfbc-ba84-4722-b88e-eb34fda15135 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANOSPEC |
| Version Model Number | C060120 |
| Catalog Number | C060120 |
| Company DUNS | 011560431 |
| Company Name | OBP CORPORATION |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M648C0601200 [Primary] |
| HIBCC | M648C0601201 [Package] Contains: M648C0601200 Package: BOX [20 Units] In Commercial Distribution |
| HIBCC | M648C0601202 [Package] Contains: M648C0601201 Package: CASE [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121604
FDA Product Code
| FER | Anoscope And Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-11-17 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [ANOSPEC ]
| M648C0601202 | 103x18mm SINGLE-USE BEVELED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
| M648C0601102 | 96mm x 23mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
| M648C0601002 | 90mm x 18mm SINGLE-USE SLOTTED ANOSCOPE WITH BUILT-IN LIGHT SOURCE |
Trademark Results [ANOSPEC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANOSPEC 85720324 4324358 Live/Registered |
OBP Medical Corporation 2012-09-04 |
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