FDA.report

Mini Ghost™

Primary DI
04046964312397
Brand
Mini Ghost™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
613864
Catalog number
613864
Device description
MG381 MINI GHOST 6MM X 1CM X 40CM
Published
2016-08-09
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

Related Records

Contact Domains

Product Codes

CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964312397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964312397040469643123974046964312397

GMDN Terms

TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
784259751
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04046961018650ACCEL®6223906223902026-03-16
04046955638499ACCEL®6139026139022024-05-12
04046955638475ACCEL®6139016139012024-05-12
04046955638406ACCEL®6139036139032024-05-12
04046955638529ACCEL®6139046139042024-05-12
04046955638543ACCEL®6139056139052024-05-12
04046955638567ACCEL®6139066139062024-05-12
04046955638581ACCEL®6139076139072024-05-12
04046955638604ACCEL®6139086139082024-05-12
04046955638628ACCEL®6139096139092024-05-12
04046955638642ACCEL®6139106139102024-05-12
04046955638666ACCEL®6139116139112024-05-12
04046955638680ACCEL®6139126139122024-05-12
04046955638703ACCEL®6139136139132024-05-12
04046955638727ACCEL®6139146139142024-05-12
04046955638741ACCEL®6139156139152024-05-12
04046955638765ACCEL®6139166139162024-05-12
04046955638789ACCEL®6139176139172024-05-12
04046955638802ACCEL®6139186139182024-05-12
04046955638826ACCEL®6139196139192024-05-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
30841156103983SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156103993SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104006SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104013SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104020SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104037SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104044SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
30841156104058SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
20801902225256ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225263ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225270ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225287ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20841156103887TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103894TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103914TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103931TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103952TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
00763000747459NAMEDTRONIC, INC.DQY2026-02-09
00763000747466NAMEDTRONIC, INC.DQY2026-02-09
00763000747473NAMEDTRONIC, INC.DQY2026-02-09
00763000747480NAMEDTRONIC, INC.DQY2026-02-09
04547327165563ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165570ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165587ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165594ASAHI Veloute C3ASAHI INTECC CO., LTD.DQY2026-02-05