FDA.reportPublic FDA data

Stainless Steel Cardiac 3 Finger Heart Retractor - Large

Primary DI
B354OSCFRLG310
Brand
Stainless Steel Cardiac 3 Finger Heart Retractor - Large
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
OS-CFR-L-3
Catalog number
OS-CFR-L-3
Device description
Stainless Steel Cardiac 3 Finger Heart Retractor - Large
Published
2016-11-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B354OSCFRLG310PackageHIBCC10Not in Commercial Distribution
B354OSCFRLG30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic wound closure threadA sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047063695
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B354OSCVORTH80Tube HolderOSCVORTH82026-10-19
B354OSCVORTH81Tube HolderOSCVORTH82026-10-19
B354OSCVORTH82Tube HolderOSCVORTH82026-10-19
B354OSCVORTH83Tube HolderOSCVORTH82026-10-19
B354OSCVORTH84Tube HolderOSCVORTH82026-10-19
B354OSCVORTH85Tube HolderOSCVORTH82026-10-19
B354OSCVORTH89Tube HolderOSCVORTH82026-10-19
B354OSCVORTH0Cardiac Tube HolderOSCVORTH2016-11-15
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B3543000011ThoraClear Y Connector3000-012025-11-25
B3543000012ThoraClear Y Connector3000-012025-11-25
B3543000013ThoraClear Y Connector3000-012025-11-25
B3543000014ThoraClear Y Connector3000-012025-11-25
B3543000015ThoraClear Y Connector3000-012025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436674MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776436704MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437657MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437770MillenniumAvalign Technologies, Inc.DWS2026-10-20
00190776437794MillenniumAvalign Technologies, Inc.DWS2026-10-20
03661219455073LANDANGERLANDANGERDWS2026-10-19
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08