FDA.reportPublic FDA data

Micro-Introducer Set

Primary DI
00841268106963
Brand
Micro-Introducer Set
Company
GALT MEDICAL CORP.
Model
INT-112-06
Catalog number
INT-112-06
Device description
Micro-Introducer Set
Published
2017-08-09
Public version status
Update
Distribution status
Not 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
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268106960PackageGS110Not in Commercial Distribution
20841268106967PackageGS1100Not in Commercial Distribution
00841268106963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810696010841268106960
2084126810696720841268106967
00841268106963008412681069638412681069630841268106963

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customersrvice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268110397Transcarotid/Peripheral Access KitKIT-075-05KIT-075-052026-08-18
00841268100015Tearaway Introducer KitKIT-064-07KIT-064-072018-02-06
00841268100022Tearaway Introducer KitKIT-064-08KIT-064-082018-02-06
00841268100039Tearaway Introducer KitKIT-064-09KIT-064-092018-02-06
00841268100046Tearaway Introducer KitKIT-064-10KIT-064-102018-02-06
00841268100053Tearaway Introducer KitKIT-064-11KIT-064-112018-02-06
00841268100060Tearaway Introducer KitKIT-064-12KIT-064-122018-02-06
00841268100213DilatorDIL-600-11DIL-600-112017-03-20
00841268100220DilatorDIL-600-12DIL-600-122017-03-20
00841268100237DilatorDIL-600-125DIL-600-1252017-03-20
00841268100244DilatorDIL-600-13DIL-600-132017-03-20
00841268100251DilatorDIL-600-14DIL-600-142017-03-20
00841268100268DilatorDIL-600-15DIL-600-152017-03-20
00841268100275DilatorDIL-600-16DIL-600-162017-03-20
00841268100282DilatorDIL-601-03DIL-601-032017-03-20
00841268100299DilatorDIL-601-04DIL-601-042017-03-20
00841268100305DilatorDIL-601-05DIL-601-052017-03-20
00841268100312DilatorDIL-601-06DIL-601-062017-03-20
00841268100329DilatorDIL-601-07DIL-601-072017-03-20
00841268100336DilatorDIL-601-08DIL-601-082017-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450499221Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499245Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499870Merit S-MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-29
10884450708443Prelude®Merit Medical Systems, Inc.DRE2026-10-29
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
00884450838105Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450839119Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450838143Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450839126Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450838204Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-02
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00884450839133Prelude Roadster™Merit Medical Systems, Inc.DRE2026-06-19
00884450839140Prelude Roadster™Merit Medical Systems, Inc.DRE2026-05-09
00884450838365Abiomed®Merit Medical Systems, Inc.DRE2025-07-01
00884450770764Prelude Roadster™Merit Medical Systems, Inc.DRE2023-12-13
00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
00884450770757Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-05
00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
00884450532522Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-15
00884450531952Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-12
00884450532348Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-01
00884450532171Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-28
00884450531914Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-19