FDA.reportPublic FDA data

SynFrame

Primary DI
10705034771205
Brand
SynFrame
Company
Synthes GmbH
Model
387.391
Catalog number
387391
Device description
SYNFRAME RETRACTOR 60MM
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, operating-room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993314000SYNTHES LIGHT GUIDESynthes (Usa)1999-12-06FQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819099487Direct MarkingGS10
10705034771205PrimaryGS10
H9813873910SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819099487076118190994877611819099487
1070503477120510705034771205

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761968547Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
06974539960002SAIKANGJiangsu Saikang Medical Equipment Co.,Ltd.FQP2023-05-31
00887761976450Pre-Install Set Helux ProBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761976474Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977334Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977341Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977358Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977365Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977389Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761970939Carbon SectionsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761974432Control UnitsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972902Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972926Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972957Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15