FDA.reportPublic FDA data

FIBRIJET

Primary DI
00815634020504
Brand
FIBRIJET
Company
Micromedics, Inc.
Model
SA-3768
Device description
360° ENDOSCOPIC APPLICATOR WITH TETHER, 5MM x 40CM, 1:1 RATIO (US Indication)
Published
2017-01-13
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122526000360 GAS ASSISTED ENDOSCOPIC APPLICATORMicromedics, Inc.2012-11-16GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815634020501PackageGS15Not in Commercial Distribution
20815634020508PackageGS11Not in Commercial Distribution
00815634020504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081563402050110815634020501
2081563402050820815634020508
00815634020504008156340205048156340205040815634020504

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery adhesive/sealant applicator, dual-channelA sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.

Regulatory Flags#

DUNS number
066839630
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00815634020511Duplotip06011362018-06-15
00815634020528DuplotipSA3740030044442018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18