FDA.reportPublic FDA data

NA

Primary DI
10888551000048
Brand
NA
Company
STERILMED, INC.
Model
LIN9971
Catalog number
9971
Device description
CTS RELIEF KIT, 5PC SET
Published
2019-08-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551000048PrimaryGS10
80888551000047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855100004810888551000048
8088855100004780888551000047

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
5
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551045735Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657485R116574852026-07-06
10888551045742Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657484R116574842026-07-06
10888551045759Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510825R115108252026-07-06
10888551045766Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510826R115108262026-07-06
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267742Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-25
D955BLAHST1Paul BandittTerlain Enterprises, Inc.GDZ2026-09-25
00724995267728Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-24
00190776429072MillenniumAvalign Technologies, Inc.GDZ2026-09-04
00724995314682V. MuellerSteris CorporationGDZ2026-08-21
00724995314699V. MuellerSteris CorporationGDZ2026-08-21
00724995314705V. MuellerSteris CorporationGDZ2026-08-21
00724995314712V. MuellerSteris CorporationGDZ2026-08-21
00724995314729V. MuellerSteris CorporationGDZ2026-08-21
00724995317362V. MuellerSteris CorporationGDZ2026-08-21
00724995317379V. MuellerSteris CorporationGDZ2026-08-21
00724995320492V. MuellerSteris CorporationGDZ2026-08-21
00724995320508V. MuellerSteris CorporationGDZ2026-08-21
00724995320515V. MuellerSteris CorporationGDZ2026-08-21
00724995320522V. MuellerSteris CorporationGDZ2026-08-21
00724995320539V. MuellerSteris CorporationGDZ2026-08-21
00724995343446V. MuellerSteris CorporationGDZ2026-08-21
04054462913466evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913473evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913480evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913527evonosevonos GmbH & Co. KGGDZ2026-08-19
00190776422837MillenniumAvalign Technologies, Inc.GDZ2026-08-03
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26