FDA.report

Trinity Sterile, Inc.

Primary DI
00841767103753
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
6001
Device description
KELLY FCP STR 5.5 STRL
Published
2023-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841767103753PackageGS1100In Commercial Distribution
10841767103750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767103753008417671037538417671037530841767103753
1084176710375010841767103750

GMDN Terms

TermDefinition
Dressing/utility forceps, scissors-like, single-useA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50649111345775Trinity Sterile, Inc.94-19242024-12-16
50649111492691Trinity Sterile, Inc.96-3566A2024-12-16
50649111449701Trinity Sterile, Inc.96-36152024-12-16
10841767198275Trinity Sterile, Inc.T97-7052025-01-06
10841767101084Trinity Sterile, Inc.T97-7482024-10-30
10841767101091Trinity Sterile, Inc.T97-7512024-10-30
10841767198282Trinity Sterile, Inc.T97-7102024-10-30
10841767198312Trinity Sterile, Inc.T97-7422024-10-30
10841767198374Trinity Sterile, Inc.T97-7712024-10-30
10841767198381Trinity Sterile, Inc.T97-7722024-10-30
10841767198398Trinity Sterile, Inc.T97-7752024-10-30
10841767198404Trinity Sterile, Inc.T97-7762024-10-30
10841767198411Trinity Sterile, Inc.T97-7772024-10-30
10841767198428Trinity Sterile, Inc.T97-7782024-10-30
10841767101237Trinity Sterile, Inc.T98-8012024-10-28
10841767101114Trinity Sterile, Inc.T97-7932024-10-25
10841767198442Trinity Sterile, Inc.T97-7912024-10-25
10841767198466Trinity Sterile, Inc.T97-8102024-10-25
10841767198473Trinity Sterile, Inc.T97-8322024-10-25
10841767198497Trinity Sterile, Inc.T97-8472024-10-25

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04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
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04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
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04058749026764NAFehling Instruments GmbH & Co. KGHXK2025-12-08
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04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016287INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-12-02
00757770676446Bausch + LombBausch & Lomb IncorporatedHXK2025-11-14
00841336107632Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHXK2025-09-28
00840314270078gSourceGSOURCE LLCHXK2025-09-21
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00810158216792PRINCETONPrinceton Medical Group, Inc.HXK2025-09-02
04058749028232NAFehling Instruments GmbH & Co. KGHXK2025-09-01
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00840217909822Wiggins medicalEbner Medical, LLCHXK2025-08-20
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00840217909853Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909860Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909884Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909907Wiggins medicalEbner Medical, LLCHXK2025-08-20