FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780427445
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
28-104
Catalog number
28-104
Device description
"Integra® Miltex® Barr Fistula Probe, 11"", 8"" Shaft"
Published
2018-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXXPROBE, RECTAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780427445PrimaryGS10
H834281040SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042744510381780427445

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613026622MSI Precision Specialty InstrumentsMed Saver, Inc.EXX2025-08-01
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04049047024477GimmiGimmi GmbHEXX2025-04-16
00840306830778Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-19
00840306830341Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830358Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830365Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840183526962BR Surgical, LLCBR Surgical, LLCEXX2024-05-29
00840306826832Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-05-10
00840306824166Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-29
00840306821684Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306821691Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306806728Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
00840306807336Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
G586UR96105210Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR96105610Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR6105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105530Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105540Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
00860001161618GreenEggEndoglow, LLCEXX2023-07-07
00840306808258Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00840306808326Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00842331181887Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331185564Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331152450Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331155468Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331131493Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331133619Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331135583Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10