FDA.reportPublic FDA data

Seamless™

Primary DI
04046955716623
Brand
Seamless™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614713
Catalog number
614713
Device description
4F x 5CM MPK 2.5CM NDL-018 NT GW AU TIP-STD
Published
2023-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
04046955716623PrimaryGS10
04046955716616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955716623040469557166234046955716623
04046955716616040469557166164046955716616

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Store at room temp

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
04046955642489Seamless™6147026147022023-06-29
04046955668823COMPASS ™6139446139442021-12-07
04046955668847COMPASS ™6139456139452021-12-07
04046955668861COMPASS ™6139466139462021-12-07
04046955668885COMPASS ™6139476139472021-12-07
04046955668908COMPASS ™6139486139482021-12-07
04046955668922COMPASS ™6139496139492021-12-07
04046955668946COMPASS ™6139506139502021-12-07
04046955668960COMPASS ™6139516139512021-12-07
04046955668984COMPASS ™6139526139522021-12-07
04046955669004COMPASS ™6139536139532021-12-07
04046955669028COMPASS ™6139546139542021-12-07
04046955669042COMPASS ™6139556139552021-12-07
04046955669066COMPASS ™6139566139562021-12-07
04046955669080COMPASS ™6139576139572021-12-07
04046955669103COMPASS ™6139586139582021-12-07
04046955669127COMPASS ™6139596139592021-12-07
04046955669141COMPASS ™6139606139602021-12-07
04046955669165COMPASS ™6139616139612021-12-07
04046955669189COMPASS ™6139626139622021-12-07

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