FDA.reportPublic FDA data

EASYGRIP FLO-41

Primary DI
55413765586113
Brand
EASYGRIP FLO-41
Company
BAXTER HEALTHCARE CORPORATION
Model
ADS201897
Catalog number
ADS201897
Device description
The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe.
Published
2020-04-08
Public version status
New
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193137000EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation2020-01-08GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55413765586113PackageGS16In Commercial Distribution
05413765586118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5541376558611355413765586113
05413765586118054137655861185413765586118

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate applicatorA hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate (e.g., thrombin, collagen, platelet concentrate, bone marrow aspirate concentrate) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length41Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001US-MEDINFO_MEDPRODUCTS@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412004747INTERLINK2N33392N33392016-09-24
00085412004785INTERLINK2N33432N33432016-09-24
00085412004792MICRO-VOLUME2N33452N33452016-09-24
00085412004808Baxter2N33462N33462016-09-24
00085412004815Micro-Volume2N33472N33472016-09-24
00085412004839Baxter2N33492N33492016-09-24
00085412036373INTERLINK2C75572C75572016-09-24
00085412036380INTERLINK2C75582C75582016-09-24
00085412046372CLEARLINK2C88572C88572016-09-24
00085412071688CLEARLINK2C88582C88582016-09-24
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08