FDA.reportPublic FDA data

TITAN CSR® Retractor

Primary DI
G254TSR1061000
Brand
TITAN CSR® Retractor
Company
Advanced Surgical Retractor Systems, Inc.
Model
TSR106-100
Catalog number
TSR106-100
Device description
The TITAN CSR® Retractor self-retaining retractor system is a latex-free, reusable system designed to provide access and exposure for surgical procedures.
Published
2022-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G254TSR1061000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(855) 415-7471info@asrsystemsinc.com

Regulatory Flags#

DUNS number
117323785
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD9183701030Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484640Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484650Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484660Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484670Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484680Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484690Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484700Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484710Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484720Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD9147091620Surgical DirectSurgical Direct, Inc.FFO2026-07-09
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
B382SD915097010Surgical DirectSurgical Direct, Inc.FFO2026-02-09
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
00899054002661Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002678Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002685Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002692Atrial Rake, Reusable, Stainless Steel, 19mm x 24mmKDL Medical, Inc.FFO2025-02-10