FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010262
Brand
Surge Cardiovascular
Company
Med Michigan Holdings, LLC
Model
CAR-1613S
Catalog number
CAR-1613S
Device description
Coronary Artery Retraction Clip, 3.0mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10817278010269PackageGS110In Commercial Distribution
00817278010262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801026910817278010269
00817278010262008172780102628172780102620817278010262

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, single-useA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
097462979
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817278010118Surge Cardiovascular213-002213-0022016-09-23
00817278010125Surge Cardiovascular213-004213-0042016-09-23
00817278010958Surge Cardiovascular213-003213-0032016-09-23
00817278010965Surge Cardiovascular213-003NS213-003NS2016-09-23
00817278012341Surge CardiovascularFEM-V1020FEM-V10202017-10-30
00817278012358Surge CardiovascularFEM-V1022FEM-V10222017-10-30
00817278012365Surge CardiovascularFEM-V1024FEM-V10242017-10-30
00817278012372Surge CardiovascularFEM-V1026FEM-V10262017-10-30
00817278012389Surge CardiovascularFEM-V1028FEM-V10282017-10-30
00817278012020Patriot ProPP-BLM-22150PP-BLM-221502024-06-04
00817278010002Surge CardiovascularSUT-010SUT-0102016-09-23
00817278010019Surge CardiovascularSUT-013SUT-0132016-09-23
00817278010026Surge Cardiovascular213-013213-0132016-09-23
00817278010156Surge Cardiovascular215-015215-0152016-09-23
00817278010163Surge Cardiovascular215-030215-0302016-09-23
00817278010170Surge Cardiovascular215-044215-0442016-09-23
00817278010224Surge CardiovascularACIPACIP2016-09-23
00817278010231Surge CardiovascularANT-1014SANT-1014S2016-09-23
00817278010248Surge CardiovascularANT-2012SANT-2012S2016-09-23
00817278010255Surge CardiovascularANT-2014SANT-2014S2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14
03661219510970LANDANGERLANDANGERDWS2026-07-12
03661219512660DELACROIX-CHEVALIERLANDANGERDWS2026-07-12
03661219528371LANDANGERLANDANGERDWS2026-07-12
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389989DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219390220DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510062DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510086DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219511687DELACROIX-CHEVALIERLANDANGERDWS2026-07-04
03661219141440DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219143499DELACROIX-CHEVALIERLANDANGERDWS2026-06-25