FDA.reportPublic FDA data

Baxter

Primary DI
10815634020617
Brand
Baxter
Company
MICROMEDICS, INC.
Model
0611128
Device description
Spray Set 360 Endoscopic Applicator with snap lock
Published
2021-04-15
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

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061092000BAXTER DUPLOSPRAY MIS APPLICATORMicromedics, Inc.2006-09-13FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815634020617PackageGS15In Commercial Distribution
20815634020614PackageGS11In Commercial Distribution
00815634020610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081563402061710815634020617
2081563402061420815634020614
00815634020610008156340206108156340206100815634020610

GMDN Terms#

Term, Definition table
TermDefinition
Fibrin sealant biochemical preparation/application kit, endoscopicA collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, seal air leaks, adhere tissues). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including an endoscopic applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the fibrin sealant. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
066839630
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815634021488Baxter 06002252025-06-18
00815634020009MITEK SPORTS MEDICINE2780112019-01-16
00815634020016MITEK SPORTS MEDICINE2780122019-01-16
00815634020030MITEK SPORTS MEDICINE2780142019-01-16
00815634020047MITEK SPORTS MEDICINE2780152019-01-16
00815634020061FIBRIJETSA-36622016-09-25
00815634020078FIBRIJETSA-36542016-09-25
00815634020108DUPLOTIP06000372016-09-25
00815634020160FIBRIJETSA-36642016-09-25
00815634020245FIBRIJETSA-36512016-09-25
00815634020290NAAMS6122016-09-25
00815634020320FibriJetSA-61112016-09-25
00815634020337Arthrex BioExpressABS-10053-102021-04-25
00815634020450OSTEOPRECISIONGD-1215-1502017-01-13
00815634020467OSTEOXPRESSGD-55152017-01-13
00815634020474DUPLOSPRAY06000292017-01-13
00815634020481DUPLOSPRAY06000302017-01-13
00815634020498DUPLOSPRAY06000332017-01-13
00815634020504FIBRIJETSA-37682017-01-13
00815634020511Duplotip06011362018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01