SynFrame 387397
GUDID 07611819099548
SYNFRAME RETRACTOR 180MM
SYNTHES (U.S.A.) LP
Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable| Primary Device ID | 07611819099548 |
| NIH Device Record Key | a2416fa9-a61d-4a19-bdf3-b65835b1e9ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynFrame |
| Version Model Number | 387.397 |
| Catalog Number | 387397 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819099548 [Direct Marking] |
| GS1 | 10705034771267 [Primary] |
| HIBCC | H9813873970 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993314
FDA Product Code
| FQP | Lamp, operating-room |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
[07611819099548]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2016-06-30 |
On-Brand Devices [SynFrame]
| H9816900800 | SYNFRAME AUXILIARY INSTRUMENT SET GRAPHIC CASE |
| H9816900290 | SYNFRAME BONE LEVER GRAPHIC CASE |
| H9816900180 | SYNFRAME RETRACTOR GRAPHIC CASE |
| H9816900170 | SYNFRAME GRAPHIC CASE |
| 07611819110168 | SYNFRAME BONE LEVER- 18MM WIDTH/190MM |
| 07611819110151 | SYNFRAME BONE LEVER- 18MM WIDTH/170MM |
| 07611819099548 | SYNFRAME RETRACTOR 180MM |
| 07611819099531 | SYNFRAME RETRACTOR 160MM |
| 07611819099517 | SYNFRAME RETRACTOR 120MM |
| 07611819099500 | SYNFRAME RETRACTOR 100MM |
| 07611819099494 | SYNFRAME RETRACTOR 80MM |
| 07611819099487 | SYNFRAME RETRACTOR 60MM |
| H981036090580 | SYNFRAME RETRACTOR-OBLIQUE 23MM WIDTH/180MM |
| H981036090560 | SYNFRAME RETRACTOR-OBLIQUE 23MM WIDTH/160MM |
| H981036090540 | SYNFRAME RETRACTOR-OBLIQUE 23MM WIDTH/140MM |
| H981036090520 | SYNFRAME RETRACTOR-OBLIQUE 23MM WIDTH/120MM |
| H981036090500 | SYNFRAME RETRACTOR-OBLIQUE 23MM WIDTH/100MM |
Trademark Results [SynFrame]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNFRAME 78943760 3268141 Live/Registered |
DEPUY SYNTHES, INC. 2006-08-03 |
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