Pilling
Improved Balfour Retractor Interchangeable Blades Extra Wide
3manufacturers in China registered for this device type
184catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FFO |
| Device type | Retractor, Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-15 |
| Record revised | 2021-01-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 0.625 to 21 in; length 7.6 to 50 cm; width 0.875 to 14.5 in; length 25 to 705 mm; width 8 to 165 mm; depth 18 to 159 mm; depth 1.75 to 70 in; width 3.2 to 20 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN003598 | 3 x 4 Sharp prongs, 5 1/2″ (14CM) | In distribution | |
| IPN003615 | Depth 32 mm | In distribution | |
| IPN005395 | Width 1.125 in | In distribution | |
| IPN003616 | Spread 3 1/8″ (8CM), Sharp, 5 3/8″ (13.5CM) | In distribution | |
| IPN005402 | Depth 22 mm | 2 | In distribution |
| IPN003625 | Spread 3 1/2″ (8.9CM), Sharp, 5 1/2″ (14CM) | In distribution | |
| IPN003623 | Spread 4 3/4″ (12CM), 1 prong, 4 3/4″ (12CM), Medium weight, Size 3 | In distribution | |
| IPN003609 | Length 20.6 cm | In distribution | |
| IPN003594 | Length 11 in | In distribution | |
| IPN003612 | Length 20.6 cm | In distribution | |
| IPN005403 | Length 7 in | In distribution | |
| IPN007625 | Length 5.063 in | 2 | In distribution |
| IPN003479 | Angle 9.5 ° | In distribution | |
| IPN003471 | In distribution | ||
| IPN005390 | Length 133 mm | In distribution | |
| IPN005394 | Width 0.875 in | In distribution | |
| IPN003588 | Malleable, Center blade 8″ (20.3cm) long x 2 1/2″ (6.3cm) wide | In distribution | |
| IPN005397 | Width 2 in | In distribution | |
| IPN003482 | Length 9.25 in | In distribution | |
| IPN005393 | Width 22 mm | 2 | In distribution |
| IPN003475 | Angle 9.5 ° | In distribution | |
| IPN003585 | Wide, Center blade 2 1/2″ (6.3cm) wide x 2 5/8″ (6.8cm) deep | In distribution | |
| IPN005397 | Width 2 in | In distribution | |
| IPN005431 | Width 7 cm | 2 | In distribution |
| IPN003614 | Depth 25 mm | In distribution | |
| IPN003572 | Spread 17″ (43.2cm), 2 x 2 Sharp prongs | In distribution | |
| IPN003468 | Length 428 mm | In distribution | |
| IPN007650 | Depth 2.15 cm | In distribution | |
| IPN005402 | Depth 22 mm | 2 | In distribution |
| IPN003590 | Length 9.25 in | In distribution | |
| IPN003466 | Length 2.75 in | In distribution | |
| IPN003473 | Width 165 mm | In distribution | |
| IPN003487 | Length 58 mm | In distribution | |
| IPN007639 | Depth 0.75 cm | In distribution | |
| IPN005431 | Width 7 cm | 2 | In distribution |
| IPN003610 | 3 x 4 Blunt prongs, 5 1/2″ (14CM) | In distribution | |
| IPN005392 | Length 55 mm | 2 | In distribution |
| IPN003581 | Length 9.75 in | In distribution | |
| IPN005396 | Length 0.625 in | In distribution | |
| IPN003602 | Length 11.5 cm | In distribution | |
| IPN003478 | Angle 9.5 ° | In distribution | |
| IPN005396 | Width 1.25 in | In distribution | |
| IPN003626 | Length 5.5 in | In distribution | |
| IPN005403 | Length 7 in | In distribution | |
| IPN002309 | Length 9 cm | In distribution | |
| IPN003567 | Length 10.5 cm | In distribution | |
| IPN007654 | Length 13.6 cm | In distribution | |
| IPN003469 | Depth 5 cm | 2 | In distribution |
| IPN003625 | Length 5.5 in | In distribution | |
| IPN003612 | 3 x 4 Blunt prongs, 8 1/4″ (20.1CM) | In distribution | |
| IPN007642 | Width 5 cm | In distribution | |
| IPN007651 | Depth 1.9 cm | In distribution | |
| IPN003604 | 3 x 4 Blunt prongs, 6 1/2″ (16.5CM) | In distribution | |
| IPN003477 | Depth 57 mm | In distribution | |
| IPN003566 | 4 x 4 Sharp prongs, Side Blade 3/8″ (9.5MM) wide, | In distribution | |
| IPN003621 | Length 4.75 in | In distribution | |
| IPN003617 | Length 18.3 cm | In distribution | |
| IPN003608 | Length 16.3 cm | In distribution | |
| IPN003597 | Length 11.5 cm | In distribution | |
| IPN006430 | Length 18.4 cm | In distribution | |
| IPN003620 | Length 4.25 in | In distribution | |
| IPN003586 | Length 8.75 in | In distribution | |
| IPN003617 | Sharp, 7″ (18CM) | In distribution | |
| IPN003569 | Length 11 in | In distribution | |
| IPN017248 | In distribution | ||
| IPN003620 | Length 4.25 in | In distribution | |
| IPN003610 | 3 x 4 Blunt prongs, 5 1/2″ (14CM) | In distribution | |
| IPN007653 | Depth 3.8 cm | In distribution | |
| IPN005398 | Width 2.5 in | In distribution | |
| IPN003609 | 3 x 4 Sharp prongs, 8 1/4″ (20.1CM) | In distribution | |
| IPN005404 | Length 7 in | In distribution | |
| IPN005399 | Length 170 mm | In distribution | |
| IPN003593 | Width 12 in | In distribution | |
| IPN005392 | Width 22 mm | 2 | In distribution |
| IPN003474 | Width 51 mm | In distribution | |
| IPN005400 | Depth 22 mm | 2 | In distribution |
| IPN003491 | Length 9 ft | In distribution | |
| IPN005394 | Length 0.625 in | In distribution | |
| IPN003591 | For left arm (blade not included) | In distribution | |
| IPN003554 | Width 6.5 cm | 2 | In distribution |
| IPN007641 | Length 11.4 cm | In distribution | |
| IPN007642 | Depth 1.5 cm | In distribution | |
| IPN003481 | Angle 9.5 ° | In distribution | |
| IPN007619 | Length 11.25 in | In distribution | |
| IPN003555 | Height 1.6 cm | 2 | In distribution |
| IPN003472 | Angle 12.7 ° | In distribution | |
| IPN005400 | Depth 22 mm | 2 | In distribution |
| IPN007654 | Length 13.6 cm | In distribution | |
| IPN003594 | Depth 4.5 in | In distribution | |
| IPN003490 | Length 259 mm | In distribution | |
| IPN003489 | Depth 5 in | In distribution | |
| IPN003627 | Spread 8 1/8″ (20.6CM), Sharp, 9″ (22.9CM) | In distribution | |
| IPN003606 | Length 24.5 cm | In distribution | |
| IPN003590 | Width 9.313 in | In distribution | |
| IPN003611 | Length 16.3 cm | In distribution | |
| IPN003598 | 3 x 4 Sharp prongs, 5 1/2″ (14CM) | In distribution | |
| IPN003607 | Length 14 cm | In distribution | |
| IPN005391 | Depth 18 mm | 2 | In distribution |
| IPN003467 | Length 21 in | In distribution | |
| IPN003591 | Length 9.25 in | In distribution | |
| IPN003582 | Standard, Center blade 2 3/4″ (7cm) wide x 1 3/4″ (4.4cm) deep | In distribution | |
| IPN003600 | Length 19.3 cm | In distribution | |
| IPN003571 | Spread 8″ (20.3cm), Side Blade 3 1/2″ (8.8cm) deep, Center blade 3 1/2″ (8.8cm) wide x 1 3/4″ (4.4cm) deep | In distribution | |
| IPN003488 | Length 84 mm | In distribution | |
| IPN003603 | 3 x 4 Blunt prongs, 5 1/2″ (14CM) | In distribution | |
| IPN003623 | Length 4.75 in | In distribution | |
| IPN005395 | Length 0.625 in | In distribution | |
| IPN017247 | In distribution | ||
| IPN003567 | Length 10.5 cm | In distribution | |
| IPN003597 | 2 x 3 Sharp prongs, 4 1/2″ (11.5CM) | In distribution | |
| IPN017657 | In distribution | ||
| IPN005404 | Length 7 in | In distribution | |
| IPN003626 | Spread 3 3/4″ (9.5CM), Sharp, 5 1/2″ (14CM) | In distribution | |
| IPN003599 | Length 16.5 cm | In distribution | |
| IPN003470 | In distribution | ||
| IPN003606 | 3 x 4 Blunt prongs, 9 1/2″ (24.5CM) | In distribution | |
| IPN003621 | Spread 3 3/4″ (9.5CM), 1 prong, 3 1/4″ (8.2CM) | In distribution | |
| IPN005393 | Length 80 mm | 2 | In distribution |
| IPN007652 | Length 7.25 in | In distribution | |
| IPN003614 | Length 310 mm | In distribution | |
| IPN006429 | Length 17.5 cm | In distribution | |
| IPN003622 | Spread 3 1/4″ (8.2CM), 3 1/4″ (8.5CM) | In distribution | |
| IPN005391 | Depth 18 mm | 2 | In distribution |
| IPN003615 | Depth 32 mm | In distribution | |
| IPN003593 | Width 12 in | In distribution | |
| IPN005401 | Width 8 mm | 2 | In distribution |
| IPN003476 | Length 276 mm | In distribution | |
| IPN003589 | Depth 5.875 in | In distribution | |
| IPN007623 | Width 5.062 in | In distribution | |
| IPN007652 | Length 7.25 in | In distribution | |
| IPN003601 | 3 x 4 Sharp prongs, 9 1/2″ (24.5CM) | In distribution | |
| IPN003611 | 3 x 4 Blunt prongs, 6 1/2″ (16.5CM) | In distribution | |
| IPN003608 | 3 x 4 Sharp prongs, 6 1/2″ (16.5CM) | In distribution | |
| IPN005401 | Width 8 mm | 2 | In distribution |
| IPN003602 | 2 x 3 Blunt prongs, 4 1/2″(11.5CM) | In distribution | |
| IPN003622 | Spread 3 1/4″ (8.2CM), 3 1/4″ (8.5CM) | In distribution | |
| IPN003605 | Length 19.3 cm | In distribution | |
| IPN006429 | Spread 3 1/2″ (9CMT), 4 x 4 Blunt prongs 17 X 7MM, 6 3/4″ (17.1CMT), Contoured arms | In distribution | |
| IPN007629 | Length 16.5 in | In distribution | |
| IPN003618 | Length 2.75 in | In distribution | |
| IPN003574 | Spread 8″ (20.5cm), Side Blade 2 1/2″ (6.3cm) & 3 1/2″ (8.8cm) deep, Center blade 2 1/2″ (6.3cm) wide | In distribution | |
| IPN003566 | 4 x 4 Sharp prongs, Side Blade 3/8″ (9.5MM) wide, | In distribution | |
| IPN003601 | Length 24.5 cm | In distribution | |
| IPN007651 | Length 19.1 cm | In distribution | |
| IPN003595 | Length 140 mm | In distribution | |
| IPN003629 | 4 | In distribution | |
| IPN003600 | Length 19.3 cm | In distribution | |
| IPN006430 | Length 18.4 cm | In distribution | |
| IPN017250 | In distribution | ||
| IPN003571 | Spread 8″ (20.3cm), Side Blade 3 1/2″ (8.8cm) deep, Center blade 3 1/2″ (8.8cm) wide x 1 3/4″ (4.4cm) deep | In distribution | |
| IPN003556 | Length 12 cm | 2 | In distribution |
| IPN003572 | Width 8 in | In distribution | |
| IPN924062 | In distribution | ||
| IPN007622 | Length 9 in | In distribution | |
| IPN007653 | Length 18.3 cm | In distribution | |
| IPN002364 | Length 4.875 in | In distribution | |
| IPN003619 | Length 4.25 in | In distribution | |
| IPN003619 | Length 4.25 in | In distribution | |
| IPN003583 | Supra-pubic, Center blade 3 1/2″ (8.8cm) wide x 2 5/8″ (6.8cm) deep | In distribution | |
| IPN003589 | Length 9.375 in | In distribution | |
| IPN017291 | In distribution | ||
| IPN003607 | 3 x 4 Sharp prongs, 5 1/2″ (14CM) | In distribution | |
| IPN007641 | Length 11.4 cm | In distribution | |
| IPN007650 | Depth 2.15 cm | In distribution | |
| IPN003584 | Narrow, Center blade 1 5/8″ (4.2cm) wide x 3 1/2″ (8.8cm) deep | In distribution | |
| IPN003483 | Length 118 mm | In distribution | |
| IPN007630 | Width 7 in | In distribution | |
| IPN002310 | Length 12 cm | In distribution | |
| IPN005399 | Length 170 mm | In distribution | |
| IPN003627 | Length 8.93 in | In distribution | |
| IPN003616 | Spread 3 1/8″ (8CM), Sharp, 5 3/8″ (13.5CM) | In distribution | |
| IPN003599 | 3 x 4 Sharp prongs, 6 1/2″ (16.5CM) | In distribution | |
| IPN007627 | Width 7.5 in | In distribution | |
| IPN003605 | Length 19.3 cm | In distribution | |
| IPN003569 | Height 2.5 in | In distribution | |
| IPN003604 | Length 16.5 cm | In distribution | |
| IPN003587 | Malleable, Center blade 7 3/4″ (19.7cm) long x 2″ (5.0cm) wide | In distribution | |
| IPN003575 | Width 8 in | In distribution | |
| IPN003618 | Length 2.75 in | In distribution | |
| IPN007639 | Width 5 cm | In distribution | |
| IPN003595 | Width 110 mm | In distribution | |
| IPN005398 | Length 0.625 in | In distribution | |
| IPN005389 | Width 2 in | In distribution | |
| IPN003603 | Length 13.8 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,870 |
| Omni-Tract® | Integra Lifesciences Corporation | 347 |
| Mediflex Universal Round Bar Table Mounted Retractor Systems | Flexbar Machine Corp. | 271 |
| Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 209 |
| Sklar® | Sklar Corporation | 203 |
| Hayden Medical | Hayden Medical Inc | 172 |
| V. Mueller | Steris Corporation | 158 |
| Ambler Surgical | Ambler Surgical, LLC | 118 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 115 |
| Aesculap | Aesculap AG | 107 |
| Mini-Bookler Table Mounted Retractor Systems | Flexbar Machine Corp. | 105 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 56 |
Showing 12 of 178. All products under Retractor, Self-Retaining
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.