| Primary Device ID | 00190660216481 |
| NIH Device Record Key | 4f1c0bba-a1d0-494c-a56b-3a0b3d31f55e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambler Value Line |
| Version Model Number | Cottle septum speculum |
| Catalog Number | 186-286 |
| Company DUNS | 015272206 |
| Company Name | AMBLER SURGICAL CORP. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com | |
| Phone | +1(888)407-0006 |
| sales@amblersurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190660216481 [Primary] |
| EPY | SPECULUM, ENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
[00190660216481]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-12 |
| Device Publish Date | 2021-01-04 |
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| 00190660214593 | Sawyer rectal retractor, 11'', small, 2 3/4'' long x 3/4'' wide blade, grip handle |
| 00190660214586 | Sawyer rectal retractor, 11'', medium, 3 1/4'' long x 1 1/8'' wide blade, grip handle |
| 00190660214579 | Sawyer rectal retractor, 11'', large, 3 1/2'' long x 1 1/2'' wide blade, grip handle |
| 00190660214241 | Deaver retractor, 8'' long x 1'' wide blade, flat handle |
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| 00190660212247 | Castaneda suture tag forceps, 3 3/4'', #1, straight, smooth jaws, ring handle |
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| 00190660211493 | Bumm uterine curette, 12'', malleable, 15.0mm wide, sharp edge, fenestrated handle |
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