| Primary Device ID | 00190660213527 |
| NIH Device Record Key | b956ae74-dd63-44b6-a55a-2443c7ebd993 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambler Value Line |
| Version Model Number | Ryder micro needle holder |
| Catalog Number | 153-471 |
| 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 | 00190660213527 [Primary] |
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
Moist Heat or Steam Sterilization
[00190660213527]
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 |
| 00190660218843 | Mayo-Hegar needle holder, 5'', straight, serrated TC jaws, gold ring handle |
| 00190660217631 | Buie pile clamp, 8 1/4'', cuved, serrated jaws, ring handle |
| 00190660216788 | Tieck nasal speculum, 5 1/2'', infant size, 18.0mm blades |
| 00190660216733 | Pratt rectal speculum, 8 1/2'', 3 1/2'' long x 1'' diameter, with set screw |
| 00190660216603 | Killian septum speculum, 5 1/2'', size #4, extra-large, 90.0mm blades, with set screw |
| 00190660216597 | Killian septum speculum, 5 1/2'', size #3, large, 76.0mm blades, with set screw |
| 00190660216580 | Killian septum speculum, 5 1/2'', size #2, medium, 64.0mm blades, with set screw |
| 00190660216573 | Killian septum speculum, 5 1/2'', size #1, small, 51.0mm blades, with set screw |
| 00190660216481 | Cottle septum speculum, 5 1/2'', narrow, 90.0mm long, tapered 10mm to 8mm wide blades, with set |
| 00190660214654 | Weitlaner self-retaining retractor, 9 1/2'', 3x4 sharp prongs, ring handle with ratchet catch |
| 00190660214647 | Weitlaner self-retaining retractor, 9 1/2'', 3x4 blunt prongs, ring handle with ratchet catch |
| 00190660214630 | Weitlaner self-retaining retractor, 8'', 3x4 sharp prongs, ring handle with ratchet catch |
| 00190660214623 | Weitlaner self-retaining retractor, 8'', 3x4 blunt prongs, ring handle with ratchet catch |
| 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 |
| 00190660214234 | Deaver retractor, 13'' long x 1'' wide blade, flat handle |
| 00190660214227 | Deaver retractor, 12'' long x 3'' wide blade, flat handle |
| 00190660214210 | Deaver retractor, 12'' long x 2'' wide blade, flat handle |
| 00190660214203 | Deaver retractor, 12'' long x 1'' wide blade, flat handle |
| 00190660214197 | Deaver retractor, 12'' long x 1 1/2'' wide blade, flat handle |
| 00190660214173 | Crile retractor, 4 1/4'', #2, double-ended, 1/4'' x 1/2'' and 3/8'' x 7/8'' blades, flat handle |
| 00190660213527 | Ryder micro needle holder, 8'', straight, 1.0mm smooth TC jaws, gold ring handle |
| 00190660213329 | Halsey needle holder, 5'', straight, smooth jaws, ring handle |
| 00190660213305 | Cooley microvascular needle holder, 6 3/4'', delicate, straight, serrated TC jaws, gold ring han |
| 00190660213138 | Cottle mallet, 7 1/2'', 12.0 oz. head weight, 32.0mm diameter, one flat end, one round end |
| 00190660212278 | Castaneda suture tag forceps, 3 3/4'', #4, straight, smooth jaws, ring handle |
| 00190660212261 | Castaneda suture tag forceps, 3 3/4'', #3, straight, smooth jaws, ring handle |
| 00190660212254 | Castaneda suture tag forceps, 3 3/4'', #2, straight, smooth jaws, ring handle |
| 00190660212247 | Castaneda suture tag forceps, 3 3/4'', #1, straight, smooth jaws, ring handle |
| 00190660212094 | Pennington septum elevator, 8 1/4'', double-ended, strongly curved, 6.0mm x 9.0mm and 6.0mm x 11 |
| 00190660212087 | McKenty periosteal elevator, 5 1/2'', curved, 4.0mm wide blade, flat handle |
| 00190660212056 | Cottle septum elevator, 8 1/2'', double-ended, graduated shaft, 4.0mm x 4.0mm round end, 3.0mm w |
| 00190660212049 | Cottle septum elevator, 8 1/2'', double-ended, 4.5mm wide blades, flat handle |
| 00190660211981 | Sims uterine sound, 13'', malleable shaft, inch scale, flat handle, sterling silver |
| 00190660211974 | Sims uterine sound, 13'', malleable shaft, cm scale, flat handle, steriling silver |
| 00190660211967 | Simpson uterine sound, 13'', malleable shaft, inch scale, flat handle |
| 00190660211554 | Bumm uterine curette, 12'', malleable, 21.0mm wide, sharp edge, fenestrated handle |
| 00190660211547 | Bumm uterine curette, 12'', malleable, 21.0mm wide, blunt edge, fenestrated handle |
| 00190660211530 | Bumm uterine curette, 12'', malleable, 19.0mm wide, sharp edge, fenestrated handle |
| 00190660211523 | Bumm uterine curette, 12'', malleable, 19.0mm wide, blunt edge, fenestrated handle |
| 00190660211516 | Bumm uterine curette, 12'', malleable, 17.0mm wide, sharp edge, fenestrated handle |
| 00190660211509 | Bumm uterine curette, 12'', malleable, 17.0mm wide, blunt edge, fenestrated handle |
| 00190660211493 | Bumm uterine curette, 12'', malleable, 15.0mm wide, sharp edge, fenestrated handle |
| 00190660211486 | Bumm uterine curette, 12'', malleable, 15.0mm wide, blunt edge, fenestrated handle |
| 00190660211479 | Bumm uterine curette, 12'', malleable, 13.0mm wide, sharp edge, fenestrated handle |
| 00190660211462 | Bumm uterine curette, 12'', malleable, 13.0mm wide, blunt edge, fenestrated handle |
| 00190660211455 | Bumm uterine curette, 12'', malleable, 11.0mm wide, sharp edge, fenestrated handle |
| 00190660211448 | Bumm uterine curette, 12'', malleable, 11.0mm wide, blunt edge, fenestrated handle |