FDA.reportPublic FDA data

IBC Aortic Punch, Medium, 4.0mm

Primary DI
10814321020312
Brand
IBC Aortic Punch, Medium, 4.0mm
Company
Movair, Inc.
Model
APM40
Device description
The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Published
2016-08-02
Public version status
Update
Distribution status
Not 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
10814321020312PrimaryGS10
00814321020315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081432102031210814321020312
00814321020315008143210203158143210203150814321020315

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788403103
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013561406MPVMV50012025-03-12
00860013561413MPVMV50002025-03-12
10814321020152"FloProbe 1/4’’ x 1/4"" (Non Sterile)"3090N2016-07-12
10814321020176FloProbe 3/8’’ x 3/8” (Non Sterile)3080N 2016-07-12
10814321020213IBC Aortic Punch, Long, 2.8mmAPL282016-08-02
10814321020220IBC Aortic Punch, Long, 3.6mmAPL36 2016-08-02
10814321020237IBC Aortic Punch, Long, 4.0mmAPL402016-08-02
10814321020244IBC Aortic Punch, Long, 4.4mmAPL442016-08-02
10814321020251IBC Aortic Punch, Long, 4.8mmAPL482016-08-02
10814321020268IBC Aortic Punch, Long, 5.2mmAPL522016-08-02
10814321020275IBC Aortic Punch, Long, 5.6mmAPL562016-08-02
10814321020282IBC Aortic Punch, Long, 6.0mmAPL602016-08-02
10814321020299IBC Aortic Punch, Medium, 2.8mmAPM282016-08-02
10814321020305IBC Aortic Punch, Medium, 3.6mmAPM362016-08-02
10814321020329IBC Aortic Punch, Medium, 4.4mmAPM442016-08-02
10814321020336IBC Aortic Punch, Medium, 4.8mmAPM482016-08-02
10814321020343IBC Aortic Punch, Medium, 5.2mmAPM522016-08-02
10814321020350IBC Aortic Punch, Medium, 5.6mmAPM562016-08-02
10814321020367IBC Aortic Punch, Medium, 6.0mmAPM602016-08-02
00814321020438FloPump6500S6500S2021-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800683Adler Instrument CompanyAdler, Inc.DWS2026-11-05
B382SD902171200Surgical DirectSurgical Direct, Inc.DWS2026-11-04
M944TL034010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034310Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034410Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034510Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034710Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034810Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034910Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL036110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL044610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL044710Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27