Integra® Miltex®
Integra® Miltex® Gigli-Strully Saw Handle 2-1/2", T-Shape, Rigid, with Snap-Lock, Pair
4manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GDR |
| Device type | Saw, Manual And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-26 |
| Record revised | 2025-03-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 12 in |
| Distribution end date | 2022-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27-1561 | 8-1/2″ | In distribution |
| 26-134 | In distribution | |
| 26-130 | In distribution | |
| 27-1564 | In distribution | |
| 26-120 | In distribution | |
| 26-119 | In distribution | |
| 27-1560 | 11-1/2″ | In distribution |
| 26-138 | Length 12 in | In distribution |
| MH26-119 | In distribution | |
| 26-132 | In distribution | |
| 26-122 | In distribution | |
| 26-124 | In distribution | |
| MH26-124 | In distribution | |
| 27-1550 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 20 |
| Aesculap | Aesculap AG | 19 |
| gSource | Gsource, LLC. | 16 |
| ACE | Ace Surgical Supply Co., Inc. | 14 |
| Boss Instruments | Boss Instruments, Ltd. | 11 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 10 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 10 |
| Kmedic | Teleflex Medical LLC | 8 |
| Millennium | Avalign Technologies, Inc. | 7 |
Showing 12 of 46. All products under Saw, Manual And Accessories
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.